Share
Apr
8
Mon
PMA Drafting Seminars
Apr 8 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
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
10
Mon
PMA Drafting Seminars
Jun 10 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
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
Aug
12
Mon
PMA Drafting Seminars
Aug 12 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
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
Oct
14
Mon
PMA Drafting Seminars
Oct 14 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
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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 


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Dec
9
Mon
PMA Drafting Seminars
Dec 9 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
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 


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