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Feb
5
Mon
Fundamentals of Regulatory Affairs in Medical Devices
Feb 5 @ 1:00 PM – 2:00 PM

LIVE Online Seminar Programs in Regulatory Affairs

webinar-orangeThe Fundamentals of Regulatory Affairs in Medical Devices (“Device Program”)

Course Description

  1. Each class consists of 60-minutes of online seminar (LIVE or recorded)
  2. There are four classes for each program.
  3. The Drug Program begins on the First Mondays of January, March, May, July, September, November.
    • LIVE | 10:00 AM PST | 01:00 PM | Flexible Scheduling | 60 Minutes 
  4. The Device Program begins on the First Mondays of February, April, June, August, October, December.
    • LIVE | 10:00 AM PST | 01:00 PM EST | | Flexible Scheduling  | 60 Minutes
  5. Price for each program.
    • $799 for one attendee
    • $1,599 for up to three (3) attendees or $1,999 for up to five (5) attendees
    • $999 for recorded seminars (access to one attendee for 6 months) for either devices or drugs.
  6. Instructor:  Dr. David Lim, President and Principal of REGULATORY DOCTOR

About the Instructor

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 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.  Dr. Lim serves as a Member of the Advisory Board for “Inspection Insider” published by the FDA News as well as for “International Journal of Vaccines and Immunizations.”

Four (4) Online Classes for Drugs

  1. US Laws and Regulations Governing Drugs
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Drug Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational New Drug Application (IND): Content and Format
  4. New Drug Application (NDA): Content and Format

Four (4) Online Classes for Medical Devices

  1. US Laws and Regulations Governing Medical Devices including In Vitro Diagnostic (Medical) Devices (IVDs)
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Medical Device Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational Device Exemption (IDE): Content and Format
  4. Premarket Notification (510(k)) and Premarket Approval (PMA) Application

Registration Options

NOTE: upon registration, you will receive an email to schedule your online classes based on your availability and convenience.

LIVE (one attendee for devices): $799  

LIVE (up to 3 attendees for devices): $1599 

LIVE (more than 4 attendees for devices): $1999 

RECORDED for drugs: $999  

RECORDED  for devices: $999 

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The Fundamentals of Regulatory Affairs
Feb 5 @ 1:00 PM – 2:00 PM

Two LIVE Online Programs in Regulatory Affairs

webinar-orangeThe Fundamentals of Regulatory Affairs for Drugs (“Drug Program“) and Medical Devices (“Device Program“)

Course Description

  1. Each class consists of 60-minutes of online seminar (LIVE or recorded)
  2. There are four classes for each program.
  3. The Drug Program begins on the First Mondays of January, March, May, July, September, November.
    • LIVE | 10:00 AM PST | 01:00 PM | Flexible Scheduling | 60 Minutes 
  4. The Device Program begins on the First Mondays of February, April, June, August, October, December.
    • LIVE | 10:00 AM PST | 01:00 PM EST | | Flexible Scheduling  | 60 Minutes
  5. Price for each program.
    • $799 for one attendee
    • $1,599 for up to three (3) attendees
    • $1,999 for more than four (4) attendees
    • $999 for recorded seminars (access to one attendee for 6 months) for either devices or drugs.
  6. Instructor:  Dr. David Lim, President and Principal of REGULATORY DOCTOR

About the Instructor

David Lim Photo.JPG
Dr. David Lim | Seminar Speaker

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.

Drug Program: Four (4) Online Classes

  1. US Laws and Regulations Governing Drugs
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Drug Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational New Drug Application (IND): Content and Format
  4. New Drug Application (NDA): Content and Format

Device Program: Four (4) Online Classes

  1. US Laws and Regulations Governing Medical Devices including In Vitro Diagnostic (Medical) Devices (IVDs)
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Medical Device Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational Device Exemption (IDE): Content and Format
  4. Premarket Notification (510(k)) and Premarket Approval (PMA) Application

Registration Options

NOTE: upon registration, you will receive an email to schedule your online classes based on your availability and convenience.

LIVE (one attendee for drugs): $799 

LIVE (up to 3 attendees for drugs): $1599 

LIVE (more than 4 attendees for drugs): $1999 

LIVE (one attendee for devices): $799  

LIVE (up to 3 attendees for devices): $1599 

LIVE (more than 4 attendees for devices): $1999 

RECORDED for drugs: $999  

RECORDED  for devices: $999 

The Fundamentals of Regulatory Affairs in Drugs or Medical Devices
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Feb
8
Thu
Implementing Medical Device Complaint Handling Systems
Feb 8 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

Implementing Medical Device Complaint Handling Systems

  • Date: April 13, 2017
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Thursdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes

About the Seminar

0937-Complaint HandlingThis presentation is intended to help global medical device firms and stakeholders adequately implement FDA-compliant medical device complaint handling systems.  Even if it is believed that the similar or relevant procedures have been implemented in your firms, it is time to ensure all aspects of the requirements are under check.

To achieve compliance and to remain compliant with the FDA-compliant complaint handling systems, it is imperative that the firms accurately interpret, understand, and implement the requirements for handling all complaints (electronic, written, or ORAL).

In this 60-min presentation, the speaker will guide you through the details of the required elements to successfully implement the medical device complaint handling systems in your firms.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations
  2. Definitions
  3. Regulatory Requirements and Compliance
  4. Applicable Processes and Procedures
  5. What to Do When a Complaint Is Received
  6. What/How/When to Investigate a Complaint
  7. Complaint Investigation: Contents of Records
  8. Adjudicating Complains
  9. Implementing Interactive Systems (Complaints, MDR, and CAPA)
  10. Numerous Case Studies
  11. Speaker’s PASS-IT suggestions and recommendations
  12. Conclusion

About the Intended Attendee(s)

  • Complaint Managers
  • Regulatory Affairs
  • Quality
  • Clinical Affairs
  • R&D engineers and scientists, managers, directors, VPs
  • Compliance and Legal Affairs
  • CRO
  • Auditors and Consultants
  • Senior Management
  • Anyone Interested in Medical Device Complaint Handling Systems

About the Seminar Speaker

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, guidance, and regulatory requirements 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. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

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Feb
20
Tue
Implementing Compliance Requirements for Social Media Marketing Ads and Videos
Feb 20 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

Implementing Compliance Requirements for Social Media Marketing Ads and Promotional Videos

  • Date: February 16, 2016
    • NOTE: This seminar recurrs bi-monthly on third Tuesdays.
    • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

Social Media Practices for FDA Compliance

This seminar is intended to help FDA-regulated industry adequately implement FDA-compliant social media practices including direct to consumer (DTC) marketing, advertising and promotional issues including videos to avoid FDA enforcement actions for potential misbranding of prescription drugs (humans and animals), biologics and medical devices.

On June 27, 2014, FDA issued an untitled letter to a pharmaceutical company concerning the firm’s sponsored link on the internet search engine.  FDA states:

The sponsored link provides evidence that the drug is intended for a new use for which it lacks approval, and for which its labeling does not provide adequate directions for use, which renders the drug misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or otherwise makes its distribution violative.

The U.S. Food and Drug Administration (FDA) reviewed the firm’s sponsored link on the Google as part of the FDA’s routine monitoring and surveillance program by the Office of Prescription Drug Promotion (OPDP).  The FDA recently sent out various untitled letters to the medical device industry, citing violations for compliance concerning promotion and advertising activities.

It is imperative that firms ensure social media practices under check compliant with the applicable laws and regulations when providing FDA-cleared or approved drug or device information to the public through social media including videos for marketing, advertising or promotional purposes.

In this presentation, the speaker will discuss what to consider and proactively implement applicable elements of requirements while ensuring compliance to the laws and regulations to avoid potential FDA enforcement actions.

This 60 min seminar presentation will provide FDA-regulated industry a great opportunity to understand FDA’s perspectives on social media practices including advertising or promotional videos. You will learn about the various points for compliance that pharmaceutical and medical device firms need to consider when establishing procedures for social media marketing or advertising practices.

About the Areas to Be Discussed

  • Applicable Laws and Regulations
  • Definitions
  • FDA’s Current Thinking and Perspectives
  • Social Media Guidance(s)
  • Advertising and Promotion on Social Media – Twitter, Facebook, Videos (YouTube), WordPress and Blogger
  • Considerations for Content and Format
  • FDA Enforcements: Recent Cases
  • Preventing Non-compliance Marketing or Advertising Practices
  • PASS-IT Recommendations: Dos and Don’ts

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 premarket notification 510(k) and premarket approval (PMA) 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

  • Option 2: you may request an invoice by email to  Global Compliance Seminar
  • Option 3: you may purchase below using a credit card or PayPal below. 

LIVE (one attendee): $249 

Recorded: $299 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded: $349 

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Mar
5
Mon
The Fundamentals of Regulatory Affairs
Mar 5 @ 1:00 PM – 2:00 PM

Two LIVE Online Programs in Regulatory Affairs

webinar-orangeThe Fundamentals of Regulatory Affairs for Drugs (“Drug Program“) and Medical Devices (“Device Program“)

Course Description

  1. Each class consists of 60-minutes of online seminar (LIVE or recorded)
  2. There are four classes for each program.
  3. The Drug Program begins on the First Mondays of January, March, May, July, September, November.
    • LIVE | 10:00 AM PST | 01:00 PM | Flexible Scheduling | 60 Minutes 
  4. The Device Program begins on the First Mondays of February, April, June, August, October, December.
    • LIVE | 10:00 AM PST | 01:00 PM EST | | Flexible Scheduling  | 60 Minutes
  5. Price for each program.
    • $799 for one attendee
    • $1,599 for up to three (3) attendees
    • $1,999 for more than four (4) attendees
    • $999 for recorded seminars (access to one attendee for 6 months) for either devices or drugs.
  6. Instructor:  Dr. David Lim, President and Principal of REGULATORY DOCTOR

About the Instructor

David Lim Photo.JPG
Dr. David Lim | Seminar Speaker

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.

Drug Program: Four (4) Online Classes

  1. US Laws and Regulations Governing Drugs
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Drug Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational New Drug Application (IND): Content and Format
  4. New Drug Application (NDA): Content and Format

Device Program: Four (4) Online Classes

  1. US Laws and Regulations Governing Medical Devices including In Vitro Diagnostic (Medical) Devices (IVDs)
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Medical Device Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational Device Exemption (IDE): Content and Format
  4. Premarket Notification (510(k)) and Premarket Approval (PMA) Application

Registration Options

NOTE: upon registration, you will receive an email to schedule your online classes based on your availability and convenience.

LIVE (one attendee for drugs): $799 

LIVE (up to 3 attendees for drugs): $1599 

LIVE (more than 4 attendees for drugs): $1999 

LIVE (one attendee for devices): $799  

LIVE (up to 3 attendees for devices): $1599 

LIVE (more than 4 attendees for devices): $1999 

RECORDED for drugs: $999  

RECORDED  for devices: $999 

The Fundamentals of Regulatory Affairs in Drugs or Medical Devices
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Mar
14
Wed
Demystifying Design Control Including DHF DHR and DMR
Mar 14 @ 4:00 PM – 5:00 PM

LIVE Seminar Online

Demystifying Design Control: Design History File (DHF), Device History Record (DHR), and Device Master Record (DMR)

  • Date: June 14, 2017
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Wednesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes

Design Control

About the Seminar   

Each manufacturer of any class III or class II device, and the some class I devices shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

This presentation is intended to help you understand and adequately implement Medical Device Design Control for manufacturers and relevant stakeholders. In particular, this seminar will discuss the meaning and scope of Design History File (DHF), Device History Record (DHR), Device Master Record (DMR), and relationship between them in detail.

Design control is a subsystem of the quality management systems. Design control involves an interrelated set of practices and procedures that are incorporated into the design and development process (i.e., a system of checks and balances). Design control offers improved visibility of the design (development) process to the designers and managers.

The value of an adequate design control system includes, but is not limited to, a baseline to review the system at adequate intervals for improvements based on design history, problems, and failures of the design control system. However, in practice, an adequate documentation for DHF, DHR, and DMR has been undervalued, thereby leading to 483s and FDA warning letters. Recently, FDA issued a warning letter to a device manufacturer for design changes made to FDA cleared 510(k)s without submitting a 510(k).  Accordingly, it is imperative that device firms implement an adequate design control system.

In this 60-min presentation, seminar speaker will guide you through the details of the necessary elements in the design control systems including, DHF, DHR, and DMR.

About the Areas to Be Discussed

  • Applicable Statute(s) and Regulations
  • Definitions
  • Design and Development Planning
  • Design Input
  • Design Output
  • Design Review
  • Design Verification And Validation including Software Validation
  • Design Transfer
  • Design Changes
  • Design History File (DHF)
  • Device History Record (DHR)
  • Device Master Record (DMR)
  • Common Pitfalls (Failure to Adequately Implement Design Control)
  • How to Avoid Compliance Concerns and Non-Conformity
  • Enforcement Actions: Case Studies
  • PASS-IT Suggestions/Recommendations

About the Intended Attendee(s)

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

About the Seminar 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 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.  Dr. Lim serves as a member of Advisory Board for inspection insider at FDA News.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

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Mar
15
Thu
FDA 510k Best Practices
Mar 15 @ 3:00 PM – 4:00 PM

LIVE Seminar Online

FDA 510(k) Requirements, Submission, and Clearance: Best Practices

  • Date: June 15, 2017
  • NOTE: This 510(k) LIVE seminar recurrs tri-monthly (every three month) on 3rd Thursdays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes

About the Seminar

FDA 510(k) LIVE WebinarThis presentation will walk you through how to prepare and submit a traditional premarket notification [510(k)] for successful clearance from US FDA. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.  On July 28, 2014, FDA issued the finalized 510(k) guidance integrating a total of 400 comments received in response to the Draft Guidance issued on December 28, 2011.  To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes, prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements in your 510(k) submission for successful clearance.

About the Benefits to Attend

  • Gain and receive great guidance on 510(k) preparation, submission and clearance
  • Get the latest information
  • Learn the critical areas and common mistakes
  • Improve your current practice
  • Recognize what is important
  • Become better aware of and get familiar with the 510(k) process
  • Much more

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Device classification
  3. Who is subject to a 510(k)
  4. FDA guidance for 510(k) program, issued on July 28, 2014
  5. What actions require a 510(k) including three types of 510(k)s
  6. How to identify a predicate(s), if any.
  7. 510(k) program (Refuse to Accept Policy) – Compiled RTA Items Cited by FDA
  8. e-Copy Program
  9. Product type-specific 510(k) contents-recently cleared
  10. What to include and address in 510(k) submissions.
  11. 510(k) contents and format
  12. How to present scientific, technical, and/or clinical data.
  13. How to demonstrate substantial equivalence (SE).
  14. How to increase 510(k) submission quality.
  15. How to respond to FDA’s request of additional information.
  16. How to resolve different opinions between the submitter and FDA reviewer(s), if any.
  17. PASS-IT suggestions/recommendations

About the Intended Attendee(s)

  • Professionals from Regulatory Affairs, R&D, Clinical Affairs, Quality
  • Anyone interested in FDA 510(k) submissions.

About the Seminar Speaker

Dr. David Lim
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 regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates (ensuring to address the applicable requirements) ready for use compliant with e-Copy and RTA policy. In addition, 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. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$349 

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Apr
2
Mon
Fundamentals of Regulatory Affairs in Medical Devices
Apr 2 @ 1:00 PM – 2:00 PM

LIVE Online Seminar Programs in Regulatory Affairs

webinar-orangeThe Fundamentals of Regulatory Affairs in Medical Devices (“Device Program”)

Course Description

  1. Each class consists of 60-minutes of online seminar (LIVE or recorded)
  2. There are four classes for each program.
  3. The Drug Program begins on the First Mondays of January, March, May, July, September, November.
    • LIVE | 10:00 AM PST | 01:00 PM | Flexible Scheduling | 60 Minutes 
  4. The Device Program begins on the First Mondays of February, April, June, August, October, December.
    • LIVE | 10:00 AM PST | 01:00 PM EST | | Flexible Scheduling  | 60 Minutes
  5. Price for each program.
    • $799 for one attendee
    • $1,599 for up to three (3) attendees or $1,999 for up to five (5) attendees
    • $999 for recorded seminars (access to one attendee for 6 months) for either devices or drugs.
  6. Instructor:  Dr. David Lim, President and Principal of REGULATORY DOCTOR

About the Instructor

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 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.  Dr. Lim serves as a Member of the Advisory Board for “Inspection Insider” published by the FDA News as well as for “International Journal of Vaccines and Immunizations.”

Four (4) Online Classes for Drugs

  1. US Laws and Regulations Governing Drugs
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Drug Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational New Drug Application (IND): Content and Format
  4. New Drug Application (NDA): Content and Format

Four (4) Online Classes for Medical Devices

  1. US Laws and Regulations Governing Medical Devices including In Vitro Diagnostic (Medical) Devices (IVDs)
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Medical Device Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational Device Exemption (IDE): Content and Format
  4. Premarket Notification (510(k)) and Premarket Approval (PMA) Application

Registration Options

NOTE: upon registration, you will receive an email to schedule your online classes based on your availability and convenience.

LIVE (one attendee for devices): $799  

LIVE (up to 3 attendees for devices): $1599 

LIVE (more than 4 attendees for devices): $1999 

RECORDED for drugs: $999  

RECORDED  for devices: $999 

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The Fundamentals of Regulatory Affairs
Apr 2 @ 1:00 PM – 2:00 PM

Two LIVE Online Programs in Regulatory Affairs

webinar-orangeThe Fundamentals of Regulatory Affairs for Drugs (“Drug Program“) and Medical Devices (“Device Program“)

Course Description

  1. Each class consists of 60-minutes of online seminar (LIVE or recorded)
  2. There are four classes for each program.
  3. The Drug Program begins on the First Mondays of January, March, May, July, September, November.
    • LIVE | 10:00 AM PST | 01:00 PM | Flexible Scheduling | 60 Minutes 
  4. The Device Program begins on the First Mondays of February, April, June, August, October, December.
    • LIVE | 10:00 AM PST | 01:00 PM EST | | Flexible Scheduling  | 60 Minutes
  5. Price for each program.
    • $799 for one attendee
    • $1,599 for up to three (3) attendees
    • $1,999 for more than four (4) attendees
    • $999 for recorded seminars (access to one attendee for 6 months) for either devices or drugs.
  6. Instructor:  Dr. David Lim, President and Principal of REGULATORY DOCTOR

About the Instructor

David Lim Photo.JPG
Dr. David Lim | Seminar Speaker

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.

Drug Program: Four (4) Online Classes

  1. US Laws and Regulations Governing Drugs
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Drug Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational New Drug Application (IND): Content and Format
  4. New Drug Application (NDA): Content and Format

Device Program: Four (4) Online Classes

  1. US Laws and Regulations Governing Medical Devices including In Vitro Diagnostic (Medical) Devices (IVDs)
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Medical Device Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational Device Exemption (IDE): Content and Format
  4. Premarket Notification (510(k)) and Premarket Approval (PMA) Application

Registration Options

NOTE: upon registration, you will receive an email to schedule your online classes based on your availability and convenience.

LIVE (one attendee for drugs): $799 

LIVE (up to 3 attendees for drugs): $1599 

LIVE (more than 4 attendees for drugs): $1999 

LIVE (one attendee for devices): $799  

LIVE (up to 3 attendees for devices): $1599 

LIVE (more than 4 attendees for devices): $1999 

RECORDED for drugs: $999  

RECORDED  for devices: $999 

The Fundamentals of Regulatory Affairs in Drugs or Medical Devices
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Apr
12
Thu
Implementing Medical Device Complaint Handling Systems
Apr 12 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

Implementing Medical Device Complaint Handling Systems

  • Date: April 13, 2017
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Thursdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes

About the Seminar

0937-Complaint HandlingThis presentation is intended to help global medical device firms and stakeholders adequately implement FDA-compliant medical device complaint handling systems.  Even if it is believed that the similar or relevant procedures have been implemented in your firms, it is time to ensure all aspects of the requirements are under check.

To achieve compliance and to remain compliant with the FDA-compliant complaint handling systems, it is imperative that the firms accurately interpret, understand, and implement the requirements for handling all complaints (electronic, written, or ORAL).

In this 60-min presentation, the speaker will guide you through the details of the required elements to successfully implement the medical device complaint handling systems in your firms.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations
  2. Definitions
  3. Regulatory Requirements and Compliance
  4. Applicable Processes and Procedures
  5. What to Do When a Complaint Is Received
  6. What/How/When to Investigate a Complaint
  7. Complaint Investigation: Contents of Records
  8. Adjudicating Complains
  9. Implementing Interactive Systems (Complaints, MDR, and CAPA)
  10. Numerous Case Studies
  11. Speaker’s PASS-IT suggestions and recommendations
  12. Conclusion

About the Intended Attendee(s)

  • Complaint Managers
  • Regulatory Affairs
  • Quality
  • Clinical Affairs
  • R&D engineers and scientists, managers, directors, VPs
  • Compliance and Legal Affairs
  • CRO
  • Auditors and Consultants
  • Senior Management
  • Anyone Interested in Medical Device Complaint Handling Systems

About the Seminar Speaker

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, guidance, and regulatory requirements 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. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

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