Share
May
10
Fri
How to Most Effectively Prepare for the US RAC Exam
May 10 @ 2:00 PM – 3:30 PM

LIVE Online Seminar

How to Most Effectively Prepare for the US RAC Exam

  • Date: May 10, 2019
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 90 Minutes

About the Seminar

The keys of successHaving a credential for Regulatory Affairs Certification (RAC) can add a great value to one’s professional experience and achievement. Significant benefits of how to effectively study and prepare for the RAC examination may have been frequently neglected or considered less important, leading to spending a lot more than what is reasonably necessary to pass the exam and in many cases, professionals re-take the exam more than once. 

*: RAC stands for Regulatory Affairs Certification. In this case, it refers to the US RAC examination.  

Understanding what and how to study the relevant subjects is one of the first steps and is considered to be the most effective strategy.  An effective preparation of the RAC examination can save a significant amount of your resources (time, energy and money) and beyond (sometimes, saving some level of embarrassment).

This  seminar is intended to help you effectively prepare for the US RAC examination using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive study and understanding in a Systematic, Integrated Manner.

In this 90-min presentation, the speaker will guide you through the details of the contents for you to study (namely, WHAT and HOW) and grasp so that you can be well-prepared for the RAC exam.  

At the end of the presentation, you should be able to come up with your customized, well-guided, actionable strategy to most effectively prepare for and pass the US RAC examination. 

About the Areas to Be Discussed

  • 1st 45 Minutes
    • Overview of the US RAC Exam
    • Subject Areas
    • Applicable Laws and Regulations
    • Areas in Pharmaceuticals
    • Good Laboratory Practice (GLP)
    • Good Clinical Practice (GCP)
    • Good Manufacturing Practices (cGMPs)
    • Investigational New Drug Application (IND)
    • New Drug Application (NDA)
    • FDA Guidance Documents
    • Review of Practice Questions
  • 2nd 45 Minutes
    • Subject Areas for Biologics and Medical Devices
    • Applicable Laws and Regulations for Biologics and Medical Devices
    • Biological Products
    • Licensing Biologics
      General Biological Products Standards
    • Investigational Device Exemption
    • Premarket Notification (510(k))
    • Premarket Approval (PMA)
    • Good Manufacturing Practices (cGMPs) for Medical Devices
    • FDA Guidance Documents
    • Review of Practice Questions

NOTE:  Your attendance of this seminar will save you a significant amount of time, energy and efforts while preparing for your successful RAC examination.  

About the Intended Attendee(s)

  • Regulatory Affairs
  • Scientists
  • Engineers
  • Healthcare Professionals
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. 

Recent Testimonials

  • I want to thank you for an excellent seminar on US RAC Prep. – RA Professional with 15 Years Experience in Pharmaceutical Industry
  • I found the presentation slides to be quite thorough and extremely useful. – Regulatory Affairs Manager
  • The seminar was very helpful. – RA Professional
  • I found it very helpful for my preparation – Sr. RA Professional.
  • David Lim’s seminar helped me develop a strategy for pasting the US exam. I took the exam in the early part of Nov 2015 and left the exam with confidence his program thoroughly prepared me for the exam’s tricks, and nuances. – RA Professional in Pharmaceutical Industry
  • I just received my RAC-US in December, and I am very happy. This would not have been possible without your help and support. Thank you very, very much. – Regulatory Consultant
  • I would like to let you know that I passed the RAC (US) exam. I am very thankful for your kind advice and for your PowerPoint presentation during my exam preparation. They were very helpful. I am planning to make a full time career in regulatory affairs. – Associate Director/Regulatory Affairs Professional
  • Excellent slides, you put together a lot of very useful information! – Director of Business Development

Registration Options

Date: Recently Recorded Version

  • Recorded$299 

Date:  April 12, 2019

Time: 09:00 AM PST | 12:00 PM EST

Duration: 90 Minutes

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 4 attendees): $499 

LIVE (≥ 5 attendees): $799 

LIVE & Recorded$399 


Share
Jun
11
Tue
Establishing an FDA-Compliant UDI System
Jun 11 @ 1:00 PM – 2:00 PM

LIVE Online Seminar

Establishing an FDA-Compliant UDI System

  • Date: June 11, 2019
  • NOTE: This seminar recurs tri-monthly (every three month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 10:00 AM PST | 01:00 PM EST
  • Duration: 60 Minutes

About the Seminar

FDA UDI-LabelThis seminar is intended to help you effectively implement a unique device identification (UDI) system (UDI system) based on the final rules issued on September 20, 2013 and published in federal register on September 24, 2013. This final rule is effective 90 days after date of publication in the federal register.  Specifically, new changes in the final rules will be discussed, contributing to saving an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.

In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution. According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement.  The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology. If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself.

The speaker will present how to implement the UDI system requirements in a CAC-SI manner.

*: CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details.  You will have opportunities to bring great value and benefits to your firm’s implementation of a UDI system in an efficient and effective manner.

About the Areas to Be Discussed

  • Applicable Statute(S), Regulations and Enforcement Authority
  • Definitions
  • UDI Development History
  • UDI Final Rules: Technical Requirements and Changes Made
  • When to Use a UDI and When to Discontinue Its Use
  • UDI System Requirements including Technical Standards
  • Requirements for a Unique Device Identifier
  • FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
  • UDI Rules: Applicability
  • UDI Rules: Exceptions and Alternatives
  • Devices at a Retail Store
  • Devices Delivered to Health Care Facility, Outpatient Treatment Facility, Nursing Home, Ambulatory Surgical Center, and Hospitals
  • Devices Labeled Prior to Compliance Dates
  • Devices (Single Use, Custom, Intended for Export, Convenience Kits, Combination Products, Medical Procedure Kits and Trays)
  • Class I Devices: cGMPs Exempted
  • When to Request Exceptions and Modifications
  • Which Devices Not Required to Have a Production Identifier
  • Direct Marking Requirements and Revised Changes
  • Requirements for Stand-Alone Software
  • Use and Discontinuation of a UDI and When to Use a New UDI
  • Compliance Dates for the Applicable Requirements Over Seven (7) Years
  • Device Identifier Formats including Dates
  • Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
  • Impact of the Final Rules to Many Business Areas/Processes
  • Changes in Device Design, Documentation and Manufacturing Processes
  • Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast
  • Conclusion

About the Intended Attendee(s)

  • R&D Scientists, Managers, Directors, and VPs
  • Regulatory Affairs and Compliance Professionals
  • Clinical Affairs Professionals
  • Quality Professionals
  • Consultants
  • Legal and Compliance Officers
  • Marketing Professionals
  • Senior Management
  • Anyone Interested in the Subject

About the Seminar Speaker

Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Jul
12
Fri
How to Most Effectively Prepare for the US RAC Exam
Jul 12 @ 2:00 PM – 3:30 PM

LIVE Online Seminar

How to Most Effectively Prepare for the US RAC Exam

  • Date: May 10, 2019
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 90 Minutes

About the Seminar

The keys of successHaving a credential for Regulatory Affairs Certification (RAC) can add a great value to one’s professional experience and achievement. Significant benefits of how to effectively study and prepare for the RAC examination may have been frequently neglected or considered less important, leading to spending a lot more than what is reasonably necessary to pass the exam and in many cases, professionals re-take the exam more than once. 

*: RAC stands for Regulatory Affairs Certification. In this case, it refers to the US RAC examination.  

Understanding what and how to study the relevant subjects is one of the first steps and is considered to be the most effective strategy.  An effective preparation of the RAC examination can save a significant amount of your resources (time, energy and money) and beyond (sometimes, saving some level of embarrassment).

This  seminar is intended to help you effectively prepare for the US RAC examination using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive study and understanding in a Systematic, Integrated Manner.

In this 90-min presentation, the speaker will guide you through the details of the contents for you to study (namely, WHAT and HOW) and grasp so that you can be well-prepared for the RAC exam.  

At the end of the presentation, you should be able to come up with your customized, well-guided, actionable strategy to most effectively prepare for and pass the US RAC examination. 

About the Areas to Be Discussed

  • 1st 45 Minutes
    • Overview of the US RAC Exam
    • Subject Areas
    • Applicable Laws and Regulations
    • Areas in Pharmaceuticals
    • Good Laboratory Practice (GLP)
    • Good Clinical Practice (GCP)
    • Good Manufacturing Practices (cGMPs)
    • Investigational New Drug Application (IND)
    • New Drug Application (NDA)
    • FDA Guidance Documents
    • Review of Practice Questions
  • 2nd 45 Minutes
    • Subject Areas for Biologics and Medical Devices
    • Applicable Laws and Regulations for Biologics and Medical Devices
    • Biological Products
    • Licensing Biologics
      General Biological Products Standards
    • Investigational Device Exemption
    • Premarket Notification (510(k))
    • Premarket Approval (PMA)
    • Good Manufacturing Practices (cGMPs) for Medical Devices
    • FDA Guidance Documents
    • Review of Practice Questions

NOTE:  Your attendance of this seminar will save you a significant amount of time, energy and efforts while preparing for your successful RAC examination.  

About the Intended Attendee(s)

  • Regulatory Affairs
  • Scientists
  • Engineers
  • Healthcare Professionals
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. 

Recent Testimonials

  • I want to thank you for an excellent seminar on US RAC Prep. – RA Professional with 15 Years Experience in Pharmaceutical Industry
  • I found the presentation slides to be quite thorough and extremely useful. – Regulatory Affairs Manager
  • The seminar was very helpful. – RA Professional
  • I found it very helpful for my preparation – Sr. RA Professional.
  • David Lim’s seminar helped me develop a strategy for pasting the US exam. I took the exam in the early part of Nov 2015 and left the exam with confidence his program thoroughly prepared me for the exam’s tricks, and nuances. – RA Professional in Pharmaceutical Industry
  • I just received my RAC-US in December, and I am very happy. This would not have been possible without your help and support. Thank you very, very much. – Regulatory Consultant
  • I would like to let you know that I passed the RAC (US) exam. I am very thankful for your kind advice and for your PowerPoint presentation during my exam preparation. They were very helpful. I am planning to make a full time career in regulatory affairs. – Associate Director/Regulatory Affairs Professional
  • Excellent slides, you put together a lot of very useful information! – Director of Business Development

Registration Options

Date: Recently Recorded Version

  • Recorded$299 

Date:  April 12, 2019

Time: 09:00 AM PST | 12:00 PM EST

Duration: 90 Minutes

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 4 attendees): $499 

LIVE (≥ 5 attendees): $799 

LIVE & Recorded$399 


Share
Sep
10
Tue
Establishing an FDA-Compliant UDI System
Sep 10 @ 1:00 PM – 2:00 PM

LIVE Online Seminar

Establishing an FDA-Compliant UDI System

  • Date: June 11, 2019
  • NOTE: This seminar recurs tri-monthly (every three month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 10:00 AM PST | 01:00 PM EST
  • Duration: 60 Minutes

About the Seminar

FDA UDI-LabelThis seminar is intended to help you effectively implement a unique device identification (UDI) system (UDI system) based on the final rules issued on September 20, 2013 and published in federal register on September 24, 2013. This final rule is effective 90 days after date of publication in the federal register.  Specifically, new changes in the final rules will be discussed, contributing to saving an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.

In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution. According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement.  The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology. If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself.

The speaker will present how to implement the UDI system requirements in a CAC-SI manner.

*: CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details.  You will have opportunities to bring great value and benefits to your firm’s implementation of a UDI system in an efficient and effective manner.

About the Areas to Be Discussed

  • Applicable Statute(S), Regulations and Enforcement Authority
  • Definitions
  • UDI Development History
  • UDI Final Rules: Technical Requirements and Changes Made
  • When to Use a UDI and When to Discontinue Its Use
  • UDI System Requirements including Technical Standards
  • Requirements for a Unique Device Identifier
  • FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
  • UDI Rules: Applicability
  • UDI Rules: Exceptions and Alternatives
  • Devices at a Retail Store
  • Devices Delivered to Health Care Facility, Outpatient Treatment Facility, Nursing Home, Ambulatory Surgical Center, and Hospitals
  • Devices Labeled Prior to Compliance Dates
  • Devices (Single Use, Custom, Intended for Export, Convenience Kits, Combination Products, Medical Procedure Kits and Trays)
  • Class I Devices: cGMPs Exempted
  • When to Request Exceptions and Modifications
  • Which Devices Not Required to Have a Production Identifier
  • Direct Marking Requirements and Revised Changes
  • Requirements for Stand-Alone Software
  • Use and Discontinuation of a UDI and When to Use a New UDI
  • Compliance Dates for the Applicable Requirements Over Seven (7) Years
  • Device Identifier Formats including Dates
  • Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
  • Impact of the Final Rules to Many Business Areas/Processes
  • Changes in Device Design, Documentation and Manufacturing Processes
  • Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast
  • Conclusion

About the Intended Attendee(s)

  • R&D Scientists, Managers, Directors, and VPs
  • Regulatory Affairs and Compliance Professionals
  • Clinical Affairs Professionals
  • Quality Professionals
  • Consultants
  • Legal and Compliance Officers
  • Marketing Professionals
  • Senior Management
  • Anyone Interested in the Subject

About the Seminar Speaker

Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Sep
13
Fri
How to Most Effectively Prepare for the US RAC Exam
Sep 13 @ 2:00 PM – 3:30 PM

LIVE Online Seminar

How to Most Effectively Prepare for the US RAC Exam

  • Date: May 10, 2019
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 90 Minutes

About the Seminar

The keys of successHaving a credential for Regulatory Affairs Certification (RAC) can add a great value to one’s professional experience and achievement. Significant benefits of how to effectively study and prepare for the RAC examination may have been frequently neglected or considered less important, leading to spending a lot more than what is reasonably necessary to pass the exam and in many cases, professionals re-take the exam more than once. 

*: RAC stands for Regulatory Affairs Certification. In this case, it refers to the US RAC examination.  

Understanding what and how to study the relevant subjects is one of the first steps and is considered to be the most effective strategy.  An effective preparation of the RAC examination can save a significant amount of your resources (time, energy and money) and beyond (sometimes, saving some level of embarrassment).

This  seminar is intended to help you effectively prepare for the US RAC examination using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive study and understanding in a Systematic, Integrated Manner.

In this 90-min presentation, the speaker will guide you through the details of the contents for you to study (namely, WHAT and HOW) and grasp so that you can be well-prepared for the RAC exam.  

At the end of the presentation, you should be able to come up with your customized, well-guided, actionable strategy to most effectively prepare for and pass the US RAC examination. 

About the Areas to Be Discussed

  • 1st 45 Minutes
    • Overview of the US RAC Exam
    • Subject Areas
    • Applicable Laws and Regulations
    • Areas in Pharmaceuticals
    • Good Laboratory Practice (GLP)
    • Good Clinical Practice (GCP)
    • Good Manufacturing Practices (cGMPs)
    • Investigational New Drug Application (IND)
    • New Drug Application (NDA)
    • FDA Guidance Documents
    • Review of Practice Questions
  • 2nd 45 Minutes
    • Subject Areas for Biologics and Medical Devices
    • Applicable Laws and Regulations for Biologics and Medical Devices
    • Biological Products
    • Licensing Biologics
      General Biological Products Standards
    • Investigational Device Exemption
    • Premarket Notification (510(k))
    • Premarket Approval (PMA)
    • Good Manufacturing Practices (cGMPs) for Medical Devices
    • FDA Guidance Documents
    • Review of Practice Questions

NOTE:  Your attendance of this seminar will save you a significant amount of time, energy and efforts while preparing for your successful RAC examination.  

About the Intended Attendee(s)

  • Regulatory Affairs
  • Scientists
  • Engineers
  • Healthcare Professionals
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. 

Recent Testimonials

  • I want to thank you for an excellent seminar on US RAC Prep. – RA Professional with 15 Years Experience in Pharmaceutical Industry
  • I found the presentation slides to be quite thorough and extremely useful. – Regulatory Affairs Manager
  • The seminar was very helpful. – RA Professional
  • I found it very helpful for my preparation – Sr. RA Professional.
  • David Lim’s seminar helped me develop a strategy for pasting the US exam. I took the exam in the early part of Nov 2015 and left the exam with confidence his program thoroughly prepared me for the exam’s tricks, and nuances. – RA Professional in Pharmaceutical Industry
  • I just received my RAC-US in December, and I am very happy. This would not have been possible without your help and support. Thank you very, very much. – Regulatory Consultant
  • I would like to let you know that I passed the RAC (US) exam. I am very thankful for your kind advice and for your PowerPoint presentation during my exam preparation. They were very helpful. I am planning to make a full time career in regulatory affairs. – Associate Director/Regulatory Affairs Professional
  • Excellent slides, you put together a lot of very useful information! – Director of Business Development

Registration Options

Date: Recently Recorded Version

  • Recorded$299 

Date:  April 12, 2019

Time: 09:00 AM PST | 12:00 PM EST

Duration: 90 Minutes

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 4 attendees): $499 

LIVE (≥ 5 attendees): $799 

LIVE & Recorded$399 


Share
Nov
8
Fri
How to Most Effectively Prepare for the US RAC Exam
Nov 8 @ 2:00 PM – 3:30 PM

LIVE Online Seminar

How to Most Effectively Prepare for the US RAC Exam

  • Date: May 10, 2019
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 90 Minutes

About the Seminar

The keys of successHaving a credential for Regulatory Affairs Certification (RAC) can add a great value to one’s professional experience and achievement. Significant benefits of how to effectively study and prepare for the RAC examination may have been frequently neglected or considered less important, leading to spending a lot more than what is reasonably necessary to pass the exam and in many cases, professionals re-take the exam more than once. 

*: RAC stands for Regulatory Affairs Certification. In this case, it refers to the US RAC examination.  

Understanding what and how to study the relevant subjects is one of the first steps and is considered to be the most effective strategy.  An effective preparation of the RAC examination can save a significant amount of your resources (time, energy and money) and beyond (sometimes, saving some level of embarrassment).

This  seminar is intended to help you effectively prepare for the US RAC examination using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive study and understanding in a Systematic, Integrated Manner.

In this 90-min presentation, the speaker will guide you through the details of the contents for you to study (namely, WHAT and HOW) and grasp so that you can be well-prepared for the RAC exam.  

At the end of the presentation, you should be able to come up with your customized, well-guided, actionable strategy to most effectively prepare for and pass the US RAC examination. 

About the Areas to Be Discussed

  • 1st 45 Minutes
    • Overview of the US RAC Exam
    • Subject Areas
    • Applicable Laws and Regulations
    • Areas in Pharmaceuticals
    • Good Laboratory Practice (GLP)
    • Good Clinical Practice (GCP)
    • Good Manufacturing Practices (cGMPs)
    • Investigational New Drug Application (IND)
    • New Drug Application (NDA)
    • FDA Guidance Documents
    • Review of Practice Questions
  • 2nd 45 Minutes
    • Subject Areas for Biologics and Medical Devices
    • Applicable Laws and Regulations for Biologics and Medical Devices
    • Biological Products
    • Licensing Biologics
      General Biological Products Standards
    • Investigational Device Exemption
    • Premarket Notification (510(k))
    • Premarket Approval (PMA)
    • Good Manufacturing Practices (cGMPs) for Medical Devices
    • FDA Guidance Documents
    • Review of Practice Questions

NOTE:  Your attendance of this seminar will save you a significant amount of time, energy and efforts while preparing for your successful RAC examination.  

About the Intended Attendee(s)

  • Regulatory Affairs
  • Scientists
  • Engineers
  • Healthcare Professionals
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. 

Recent Testimonials

  • I want to thank you for an excellent seminar on US RAC Prep. – RA Professional with 15 Years Experience in Pharmaceutical Industry
  • I found the presentation slides to be quite thorough and extremely useful. – Regulatory Affairs Manager
  • The seminar was very helpful. – RA Professional
  • I found it very helpful for my preparation – Sr. RA Professional.
  • David Lim’s seminar helped me develop a strategy for pasting the US exam. I took the exam in the early part of Nov 2015 and left the exam with confidence his program thoroughly prepared me for the exam’s tricks, and nuances. – RA Professional in Pharmaceutical Industry
  • I just received my RAC-US in December, and I am very happy. This would not have been possible without your help and support. Thank you very, very much. – Regulatory Consultant
  • I would like to let you know that I passed the RAC (US) exam. I am very thankful for your kind advice and for your PowerPoint presentation during my exam preparation. They were very helpful. I am planning to make a full time career in regulatory affairs. – Associate Director/Regulatory Affairs Professional
  • Excellent slides, you put together a lot of very useful information! – Director of Business Development

Registration Options

Date: Recently Recorded Version

  • Recorded$299 

Date:  April 12, 2019

Time: 09:00 AM PST | 12:00 PM EST

Duration: 90 Minutes

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 4 attendees): $499 

LIVE (≥ 5 attendees): $799 

LIVE & Recorded$399 


Share
Dec
10
Tue
Establishing an FDA-Compliant UDI System
Dec 10 @ 1:00 PM – 2:00 PM

LIVE Online Seminar

Establishing an FDA-Compliant UDI System

  • Date: June 11, 2019
  • NOTE: This seminar recurs tri-monthly (every three month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 10:00 AM PST | 01:00 PM EST
  • Duration: 60 Minutes

About the Seminar

FDA UDI-LabelThis seminar is intended to help you effectively implement a unique device identification (UDI) system (UDI system) based on the final rules issued on September 20, 2013 and published in federal register on September 24, 2013. This final rule is effective 90 days after date of publication in the federal register.  Specifically, new changes in the final rules will be discussed, contributing to saving an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.

In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution. According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement.  The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology. If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself.

The speaker will present how to implement the UDI system requirements in a CAC-SI manner.

*: CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details.  You will have opportunities to bring great value and benefits to your firm’s implementation of a UDI system in an efficient and effective manner.

About the Areas to Be Discussed

  • Applicable Statute(S), Regulations and Enforcement Authority
  • Definitions
  • UDI Development History
  • UDI Final Rules: Technical Requirements and Changes Made
  • When to Use a UDI and When to Discontinue Its Use
  • UDI System Requirements including Technical Standards
  • Requirements for a Unique Device Identifier
  • FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
  • UDI Rules: Applicability
  • UDI Rules: Exceptions and Alternatives
  • Devices at a Retail Store
  • Devices Delivered to Health Care Facility, Outpatient Treatment Facility, Nursing Home, Ambulatory Surgical Center, and Hospitals
  • Devices Labeled Prior to Compliance Dates
  • Devices (Single Use, Custom, Intended for Export, Convenience Kits, Combination Products, Medical Procedure Kits and Trays)
  • Class I Devices: cGMPs Exempted
  • When to Request Exceptions and Modifications
  • Which Devices Not Required to Have a Production Identifier
  • Direct Marking Requirements and Revised Changes
  • Requirements for Stand-Alone Software
  • Use and Discontinuation of a UDI and When to Use a New UDI
  • Compliance Dates for the Applicable Requirements Over Seven (7) Years
  • Device Identifier Formats including Dates
  • Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
  • Impact of the Final Rules to Many Business Areas/Processes
  • Changes in Device Design, Documentation and Manufacturing Processes
  • Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast
  • Conclusion

About the Intended Attendee(s)

  • R&D Scientists, Managers, Directors, and VPs
  • Regulatory Affairs and Compliance Professionals
  • Clinical Affairs Professionals
  • Quality Professionals
  • Consultants
  • Legal and Compliance Officers
  • Marketing Professionals
  • Senior Management
  • Anyone Interested in the Subject

About the Seminar Speaker

Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Jan
10
Fri
How to Most Effectively Prepare for the US RAC Exam
Jan 10 @ 2:00 PM – 3:30 PM

LIVE Online Seminar

How to Most Effectively Prepare for the US RAC Exam

  • Date: May 10, 2019
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 90 Minutes

About the Seminar

The keys of successHaving a credential for Regulatory Affairs Certification (RAC) can add a great value to one’s professional experience and achievement. Significant benefits of how to effectively study and prepare for the RAC examination may have been frequently neglected or considered less important, leading to spending a lot more than what is reasonably necessary to pass the exam and in many cases, professionals re-take the exam more than once. 

*: RAC stands for Regulatory Affairs Certification. In this case, it refers to the US RAC examination.  

Understanding what and how to study the relevant subjects is one of the first steps and is considered to be the most effective strategy.  An effective preparation of the RAC examination can save a significant amount of your resources (time, energy and money) and beyond (sometimes, saving some level of embarrassment).

This  seminar is intended to help you effectively prepare for the US RAC examination using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive study and understanding in a Systematic, Integrated Manner.

In this 90-min presentation, the speaker will guide you through the details of the contents for you to study (namely, WHAT and HOW) and grasp so that you can be well-prepared for the RAC exam.  

At the end of the presentation, you should be able to come up with your customized, well-guided, actionable strategy to most effectively prepare for and pass the US RAC examination. 

About the Areas to Be Discussed

  • 1st 45 Minutes
    • Overview of the US RAC Exam
    • Subject Areas
    • Applicable Laws and Regulations
    • Areas in Pharmaceuticals
    • Good Laboratory Practice (GLP)
    • Good Clinical Practice (GCP)
    • Good Manufacturing Practices (cGMPs)
    • Investigational New Drug Application (IND)
    • New Drug Application (NDA)
    • FDA Guidance Documents
    • Review of Practice Questions
  • 2nd 45 Minutes
    • Subject Areas for Biologics and Medical Devices
    • Applicable Laws and Regulations for Biologics and Medical Devices
    • Biological Products
    • Licensing Biologics
      General Biological Products Standards
    • Investigational Device Exemption
    • Premarket Notification (510(k))
    • Premarket Approval (PMA)
    • Good Manufacturing Practices (cGMPs) for Medical Devices
    • FDA Guidance Documents
    • Review of Practice Questions

NOTE:  Your attendance of this seminar will save you a significant amount of time, energy and efforts while preparing for your successful RAC examination.  

About the Intended Attendee(s)

  • Regulatory Affairs
  • Scientists
  • Engineers
  • Healthcare Professionals
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. 

Recent Testimonials

  • I want to thank you for an excellent seminar on US RAC Prep. – RA Professional with 15 Years Experience in Pharmaceutical Industry
  • I found the presentation slides to be quite thorough and extremely useful. – Regulatory Affairs Manager
  • The seminar was very helpful. – RA Professional
  • I found it very helpful for my preparation – Sr. RA Professional.
  • David Lim’s seminar helped me develop a strategy for pasting the US exam. I took the exam in the early part of Nov 2015 and left the exam with confidence his program thoroughly prepared me for the exam’s tricks, and nuances. – RA Professional in Pharmaceutical Industry
  • I just received my RAC-US in December, and I am very happy. This would not have been possible without your help and support. Thank you very, very much. – Regulatory Consultant
  • I would like to let you know that I passed the RAC (US) exam. I am very thankful for your kind advice and for your PowerPoint presentation during my exam preparation. They were very helpful. I am planning to make a full time career in regulatory affairs. – Associate Director/Regulatory Affairs Professional
  • Excellent slides, you put together a lot of very useful information! – Director of Business Development

Registration Options

Date: Recently Recorded Version

  • Recorded$299 

Date:  April 12, 2019

Time: 09:00 AM PST | 12:00 PM EST

Duration: 90 Minutes

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 4 attendees): $499 

LIVE (≥ 5 attendees): $799 

LIVE & Recorded$399 


Share
Mar
10
Tue
Establishing an FDA-Compliant UDI System
Mar 10 @ 1:00 PM – 2:00 PM

LIVE Online Seminar

Establishing an FDA-Compliant UDI System

  • Date: June 11, 2019
  • NOTE: This seminar recurs tri-monthly (every three month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 10:00 AM PST | 01:00 PM EST
  • Duration: 60 Minutes

About the Seminar

FDA UDI-LabelThis seminar is intended to help you effectively implement a unique device identification (UDI) system (UDI system) based on the final rules issued on September 20, 2013 and published in federal register on September 24, 2013. This final rule is effective 90 days after date of publication in the federal register.  Specifically, new changes in the final rules will be discussed, contributing to saving an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.

In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution. According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement.  The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology. If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself.

The speaker will present how to implement the UDI system requirements in a CAC-SI manner.

*: CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details.  You will have opportunities to bring great value and benefits to your firm’s implementation of a UDI system in an efficient and effective manner.

About the Areas to Be Discussed

  • Applicable Statute(S), Regulations and Enforcement Authority
  • Definitions
  • UDI Development History
  • UDI Final Rules: Technical Requirements and Changes Made
  • When to Use a UDI and When to Discontinue Its Use
  • UDI System Requirements including Technical Standards
  • Requirements for a Unique Device Identifier
  • FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
  • UDI Rules: Applicability
  • UDI Rules: Exceptions and Alternatives
  • Devices at a Retail Store
  • Devices Delivered to Health Care Facility, Outpatient Treatment Facility, Nursing Home, Ambulatory Surgical Center, and Hospitals
  • Devices Labeled Prior to Compliance Dates
  • Devices (Single Use, Custom, Intended for Export, Convenience Kits, Combination Products, Medical Procedure Kits and Trays)
  • Class I Devices: cGMPs Exempted
  • When to Request Exceptions and Modifications
  • Which Devices Not Required to Have a Production Identifier
  • Direct Marking Requirements and Revised Changes
  • Requirements for Stand-Alone Software
  • Use and Discontinuation of a UDI and When to Use a New UDI
  • Compliance Dates for the Applicable Requirements Over Seven (7) Years
  • Device Identifier Formats including Dates
  • Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
  • Impact of the Final Rules to Many Business Areas/Processes
  • Changes in Device Design, Documentation and Manufacturing Processes
  • Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast
  • Conclusion

About the Intended Attendee(s)

  • R&D Scientists, Managers, Directors, and VPs
  • Regulatory Affairs and Compliance Professionals
  • Clinical Affairs Professionals
  • Quality Professionals
  • Consultants
  • Legal and Compliance Officers
  • Marketing Professionals
  • Senior Management
  • Anyone Interested in the Subject

About the Seminar Speaker

Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Mar
13
Fri
How to Most Effectively Prepare for the US RAC Exam
Mar 13 @ 2:00 PM – 3:30 PM

LIVE Online Seminar

How to Most Effectively Prepare for the US RAC Exam

  • Date: May 10, 2019
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 90 Minutes

About the Seminar

The keys of successHaving a credential for Regulatory Affairs Certification (RAC) can add a great value to one’s professional experience and achievement. Significant benefits of how to effectively study and prepare for the RAC examination may have been frequently neglected or considered less important, leading to spending a lot more than what is reasonably necessary to pass the exam and in many cases, professionals re-take the exam more than once. 

*: RAC stands for Regulatory Affairs Certification. In this case, it refers to the US RAC examination.  

Understanding what and how to study the relevant subjects is one of the first steps and is considered to be the most effective strategy.  An effective preparation of the RAC examination can save a significant amount of your resources (time, energy and money) and beyond (sometimes, saving some level of embarrassment).

This  seminar is intended to help you effectively prepare for the US RAC examination using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive study and understanding in a Systematic, Integrated Manner.

In this 90-min presentation, the speaker will guide you through the details of the contents for you to study (namely, WHAT and HOW) and grasp so that you can be well-prepared for the RAC exam.  

At the end of the presentation, you should be able to come up with your customized, well-guided, actionable strategy to most effectively prepare for and pass the US RAC examination. 

About the Areas to Be Discussed

  • 1st 45 Minutes
    • Overview of the US RAC Exam
    • Subject Areas
    • Applicable Laws and Regulations
    • Areas in Pharmaceuticals
    • Good Laboratory Practice (GLP)
    • Good Clinical Practice (GCP)
    • Good Manufacturing Practices (cGMPs)
    • Investigational New Drug Application (IND)
    • New Drug Application (NDA)
    • FDA Guidance Documents
    • Review of Practice Questions
  • 2nd 45 Minutes
    • Subject Areas for Biologics and Medical Devices
    • Applicable Laws and Regulations for Biologics and Medical Devices
    • Biological Products
    • Licensing Biologics
      General Biological Products Standards
    • Investigational Device Exemption
    • Premarket Notification (510(k))
    • Premarket Approval (PMA)
    • Good Manufacturing Practices (cGMPs) for Medical Devices
    • FDA Guidance Documents
    • Review of Practice Questions

NOTE:  Your attendance of this seminar will save you a significant amount of time, energy and efforts while preparing for your successful RAC examination.  

About the Intended Attendee(s)

  • Regulatory Affairs
  • Scientists
  • Engineers
  • Healthcare Professionals
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. 

Recent Testimonials

  • I want to thank you for an excellent seminar on US RAC Prep. – RA Professional with 15 Years Experience in Pharmaceutical Industry
  • I found the presentation slides to be quite thorough and extremely useful. – Regulatory Affairs Manager
  • The seminar was very helpful. – RA Professional
  • I found it very helpful for my preparation – Sr. RA Professional.
  • David Lim’s seminar helped me develop a strategy for pasting the US exam. I took the exam in the early part of Nov 2015 and left the exam with confidence his program thoroughly prepared me for the exam’s tricks, and nuances. – RA Professional in Pharmaceutical Industry
  • I just received my RAC-US in December, and I am very happy. This would not have been possible without your help and support. Thank you very, very much. – Regulatory Consultant
  • I would like to let you know that I passed the RAC (US) exam. I am very thankful for your kind advice and for your PowerPoint presentation during my exam preparation. They were very helpful. I am planning to make a full time career in regulatory affairs. – Associate Director/Regulatory Affairs Professional
  • Excellent slides, you put together a lot of very useful information! – Director of Business Development

Registration Options

Date: Recently Recorded Version

  • Recorded$299 

Date:  April 12, 2019

Time: 09:00 AM PST | 12:00 PM EST

Duration: 90 Minutes

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 4 attendees): $499 

LIVE (≥ 5 attendees): $799 

LIVE & Recorded$399 


Share