Share
Jun
4
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Jun 4 all-day

[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs

The following two products are recorded versions of two day LIVE online seminars.

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

  • 510(k) Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase 510(k) Submission Quality
  • Quality System Regulations
  • How to Format a Succinct and Comprehensive 510(k) Submission
  • Submission Template Reviews

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

  • Overview of PMA Process
  • PMA Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase PMA Submission Quality
  • Review of Quality System Regulations
  • How to Format a Succinct and Comprehensive PMA Submission
  • Submission Template Reviews

Purchase Options

Option 1: you may send your “request to purchase” by email to Global Compliance Seminar

Option 2: you may request an invoice by email to  Global Compliance Seminar

Option 3: you may purchase online below using a credit card or PayPal. 

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

510(k) and PMA Seminars (Access to Both): $799

Share
Fundamentals of Regulatory Affairs in Medical Devices
Jun 4 @ 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 

Share
The Fundamentals of Regulatory Affairs
Jun 4 @ 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
Share
Jun
5
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
Jun 5 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches

  • Date: June 6, 2017
  • NOTE: This LIVE seminar recurrs bi-monthly (every other month) on 1st Tuesdays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

This seminar is intended to discuss systematic and holistic approaches for medical device risk management including in vitro diagnostic medical devices (IVDs) applicable to medical device and IVD manufacturers and stakeholders.This seminar is further intended to discuss the impact of ISO 14971 on the risk management and risk-based decision making processes including its application to ISO 13485. This seminar will help attendees understand risk management tools, methods and processes applicable to the firms.  In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy.In this 60-min presentation, the speaker will guide you through the details of how to implement the systematic and holistic risk management for medical devices including IVDs.

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Risk management policy
  3. Risk management plan
  4. Risk identification, analysis and evaluation
  5. Risk analysis (severity, probability and detectability)
  6. Risk control measures
  7. Risk mitigation
  8. Risk management tools and methods
  9. ISO 14971:2007 and EN ISO 14971:2012
  10. ISO 13485:2003 and EN ISO 13485:2012
  11. Risk analysis and design control
  12. Risk analysis versus FMEA
  13. Risk analysis versus usability
  14. How to integrate risk management into the device design and development
  15. Doing risk management right without wasting resources
  16. Practical aspects (value) of risk management
  17. Risk analysis versus CE marking (MDD, IVDD, and AIMDD)
  18. Risk management for IVDs
  19. Risk analysis versus IEC 60601-1
  20. Relationship between risk management, complaint handling, MDR and CAPA

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Senior Management
  • Consultants
  • Contractors
  • Anyone Interested in the Risk Management

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. 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
Jun
6
Wed
FDA Pre-Submission and 510k Best Practices
Jun 6 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

FDA Pre-submission and 510(k); Best Practices

  • Date: November 2, 2016
  • NOTE: This 510(k) LIVE seminar recurrs monthly on 1st Wednesdays.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes.

FDA 510ks

About the Seminar

This presentation will walk you through how to prepare and submit a pre-submission package as well as 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. 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 including pre-submission (Q-submission), 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 (“Best Practices: Dos and Don’ts”) in your Q-submission as well as 510(k) submission for successful clearance. You will have opportunities to bring great value and benefit to your firm’s pre-submission, 510(k) preparation and submission for successful clearance in an efficient and effective manner.

About the Areas to Be Discussed

  • Statute(s) And Regulations
  • Definitions
  • Device Classification And Predicates
  • 510(k) Program
  • When 510(k)s Are Required
  • Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
  • Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
  • Substantial Equivalence: Factors to Consider and Special Considerations
  • Addressing e-Copy And RTA Policy Requirements
  • Applicable Standards and Guidance
  • 510(k) Contents And Format
  • Common Pitfalls and How to Prevent Them
  • What to Ensure While Preparing Your Q-Submission and a 510(k) Application
  • Responding to FDA’s Request of Additional Information.
  • Resolving Different Opinions and Interpretations
  • Best Practices for a Q-submission
  • Best Practices for a 510(k) Preparation, Submission and Clearance
  • Speaker’s PASS-IT Suggestions: Best Practices

About the Benefits to Attend

  • Gain and receive great guidance on 510(k) preparation, submission and clearance
  • Get updated with the latest information and tips
  • 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 Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Marketing
  • Consultants
  • Legal Counsel
  • Compliance Officers
  • Senior Management
  • Anyone interested in the topic.

About the Seminar Speaker

DavidLimUpdated_Cropped1
FDA 510(k) Consultant Speaker

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 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 at FDA News.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Jun
8
Fri
Medical Device Laws and Regulations in Asian Countries
Jun 8 @ 11:00 AM – 12:00 PM

LIVE Online Seminar

Medical Device Laws and Regulations in Asian Countries: China, Hong Kong, Japan and Korea

  • Date:  June 9, 2017
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Fridays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 08:00 AM PST | 11:00 AM EST
  • Duration: 60 Minutes

Medical-Device-Laws-Regulations-in-Asian-Countries

About the Seminar

This webinar is intended to help you identify and get familiar with the regulatory requirements for medical devices including in vitro diagnostics (IVDs) in Asian countries, China, Hong Kong, Japan and Korea.  In particular, we will discuss current medical device laws and regulations in these countries.

The medical devices are currently one of the fastest growing industries. The current knowledge and accurate understanding and adequate interpretation of global medical device laws, regulations and regulatory requirements have become increasingly important in our competitive global market. Global regulations of medical devices are rapidly evolving, integrating the regulatory systems of the advanced medical device regulations. To be able to achieve sustainability and to remain sustainable and competitive in Asian medical device markets, it is necessary to get familiar with applicable and relevant laws and regulations governing medical devices, further streamlining the regulatory process. To do so, we should understand the differences in regulatory frameworks (regulatory requirements and compliance) in a sustainable and effective way.

This webinar will greatly help you understand and accurately interpret applicable laws and regulations governing medical devices in China, Hong Kong, Japan and Korea.

This webinar will further help you facilitate and expedite the registration process for your medical devices including IVDs in these Asian countries.

The speaker will present the regulatory requirements for medical devices in a CAC-SI manner.  *: CAC-SI refers to current, accurate and complete/comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details of the regulatory requirements in these four Asian countries, helping you save significant amount of your time, efforts and resources.

About the Areas to Be Discussed

  1. Medical devices and in vitro diagnostics: laws and regulations in China, Hong Kong, Japan and Korea.
  2. Definitions and classification.
  3. Regulatory framework for medical devices in China, Hong Kong, Japan and Korea.
  4. Regulatory requirements for medical devices including in vitro diagnostic devices in China, Hong Kong, Japan and Korea.
  5. How to identify and address the regulatory requirements.
  6. How to establish and maintain systematic methods to meet the regulatory requirements.
  7. How to streamline the regulatory process.
  8. Culture, people, and sustainable business strategy.
  9. Instructor’s unique regulatory guide to provide practical, actionable and sustainable solutions in an integrated, through (PASS-IT) manner.
  10. Much more

About the Intended Attendee(s)

  • Professionals from Regulatory Affairs, R&D, Clinical Affairs, and Quality
  • Marketing Professionals
  • Compliance Professionals
  • Legal Counsel
  • Senior Management
  • Anyone interested in the topic.

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. Dr. Lim also developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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 Advisory Board for Inspection Insider published by FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

Error! You must specify a price for your product in the shortcode.

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$349 

Share
How to Most Effectively Prepare for the US RAC Exam
Jun 8 @ 12:00 PM – 1:30 PM

LIVE Online Seminar

How to Most Effectively Prepare for the US RAC Exam

  • Date: April 13, 2018
  • Time: 09:00 AM PST | 12:00 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. Dr. Lim serves as a member of the advisory board for inspection insider at FDA News. Dr. Lim also contributes to FDA Guidance.net, providing FDA guidance information for free to the FDA regulated industry. 

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: Recent Recorded Version: August 25, 2017

  • Recorded$299 

Date:  April 13, 2018

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
Good Social Media Practices to Avoid FDA Actions
Jun 8 @ 1:00 PM – 2:00 PM

LIVE Online Seminar

Establishing FDA-Compliant Social Media Practices to Avoid FDA Actions

SocialMediaCheckList

  • Date: December 9, 2016
    • NOTE: This seminar recurrs bi-monthly on second Fridays.
    • Time: 09:00 AM PST | 12:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

This seminar is intended to help you adequately implement good social media practices to avoid FDA enforcement actions for potential misbranding of your prescription drugs (humans and animals), biologics, and medical devices including other healthcare products (dietary supplements, cosmetics and OTCs).

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). It is imperative that firms ensure their compliance to the applicable laws and regulations when they provide drug or device information to the public through social media.

In this presentation, the speaker will discuss what to consider and how to establish your good social media practices while ensuring your compliance to the laws and regulation to avoid potential FDA enforcement actions.

This 60 min seminar presentation will provide you a great opportunity to understand FDA’s perspective on social media practices covered in FDA’s recent guidances. You will learn about the various considerations that pharmaceutical and medical device firms need to consider when establishing procedures for social media practices.

About the Areas to Be Discussed

  • Applicable Laws and Regulations
  • Definitions
  • FDA’s Current Thinking and Perspectives
  • FDA’s Three (3) Social Media Guidances Issued in December, 2011 and June, 2014
  • Best Social Media Practices
  • FDA Enforcements: Recent Cases
  • Advertising and Promotion on Social Media – Twitter, Facebook, YouTube, WordPress and Blogger
  • 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): $199 

Recorded: $249 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded: $299 

Share
LIVE 510k Webinar
Jun 8 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

FDA 510(k): Preparation, Submission, and Clearance

  • Date: November 11, 2016
  • NOTE: This 510(k) LIVE seminar recurrs monthly on 2nd Fridays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 60 Minutes.

FDA 510ks

About the Seminar

This 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. 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. You will have opportunities to bring great value and benefit to your firm’s 510(k) preparation, submission and clearance in an efficient and effective manner.

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. What actions require a 510(k) including three types of 510(k)s
  5. How to identify a predicate(s)
  6. 510(k) preparation compliant with eCopy and revised RTA policy (effective as of October 1, 2015)
  7. 510(k) content and format
  8. Writing a cover letter: importance
  9. What to include and address in 510(k) submissions
  10. FDA de novo process – current good practices
  11. How to present scientific, technical, and/or clinical data
  12. How to demonstrate substantial equivalence (SE)
  13. How to increase 510(k) submission quality
  14. How to respond to FDA’s request of additional information
  15. How to resolve different opinions between the submitter and FDA reviewer(s)
  16. Speaker’s PASS-IT suggestions/recommendations

About the Benefits to Attend

  • Gain and receive great guidance on 510(k) preparation, submission and clearance
  • Get updated with the latest information and tips
  • 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 Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Marketing
  • Consultants
  • Legal Counsel
  • Compliance Officers
  • Senior Management
  • Anyone interested in the topic.

About the Seminar Speaker

DavidLimUpdated_Cropped1
FDA 510(k) Consultant Speaker

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 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.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded: $299 

Share
Developing and Implementing a Global Regulatory Plan and Strategy
Jun 8 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Developing and Implementing a Global Regulatory Plan and Strategy

  • Date: April 13, 2018
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays.
  • 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 MinutesCompass

About the Seminar

Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued.  Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.

This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrated Manner.

In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your regulatory plan and strategy.  At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations in EU, Canada, and US
  2. Questions and Issues to Identify and Address
  3. Interfacing:  Roles and Benefits
  4. Alignments between Functional Departments/Groups
  5. What Is Critical When Implementing Global Regulatory Intelligence Program
  6. Mapping Regulatory Requirements and Pathways
  7. When/How to Prevent Costly Mistakes
  8. Best Approaches: What to Integrate
  9. Practical, Actionable, and Strategic Solutions (PASS)
  10. Speaker’s Experience and Actual Cases

About the Intended Attendee(s)

  • Regulatory Affairs
  • Research and Development (Engineers and Scientists); Product Development (Engineers and Scientists)
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. 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.  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 served as a member of the advisory board for inspection insider published by the FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$349 

 

Share