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Dec
18
Tue
Implementing Compliance Requirements for Social Media Marketing Ads and Videos
Dec 18 @ 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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Dec
21
Fri
Understanding ANDAs and Paragraph IV Patent Certifications
Dec 21 @ 1:00 PM – 2:00 PM

LIVE Online Seminar

Understanding ANDAs and Paragraph IV Patent Certifications

  • Date: December 9 , 2016
  • Time: 10:00 AM PST | 01:00 PM EST
  • Duration: 60 Minutes

About the Seminar

The regulatory requirements for generic drugs include, but not limited to, same active ingredients, same dosage form, same route of administration,  same strength, and same conditions of use compared to brand name drug product (RLD: reference listed drug).

In 1984, the Drug Price Competition and Patent Term Restoration Act (P.L. 98-417), was signed into law, which is now called “the Hatch-Waxman Act.”  The Hatch-Waxman Act is intended to expedite and streamline FDA drug review and approvals for generic drugs including and patent litigation involving generic drugs.

According to the Hatch-Waxman Act, generic drug firms can file either one of two applications to obtain FDA approval of a generic drug: 1).  An Abbreviated New Drug Application (ANDA); 2). 505(b)(2) Application. Under the Hatch-Waxman Act, there are certain market exclusivity periods for NDAs (non-patent based and patent based).

New chemical entity (NCE) exclusivity (5 years) is non-patent based.  A generic drug firm is barred from filing an ANDA due to NCE exclusivity (5 years from the first NDA approval). However, a generic drug firm may file an ANDA with a Paragraph IV patent certification pursuant to the Hatch-Waxman Act, allowing a generic drug firm to challenge a brand name drug firm’s patent exclusivity for the RLD.

This seminar is intended to help industry better understand ANDA process. In particular, it is further intended to cover Paragraphs 1-4 certifications with major focus on Paragraph IV certifications.

At the end of this seminar, you should be able to understand regulatory requirements for ANDA filings with focus on paragraph IV (para IV) certifications.  

About the Areas to Be Discussed

  • Laws and Regulations
  • Definition
  • Hatch-Waxman Act
  • Orange Book
  • Regulatory Requirements for Generic ANDA and 505(b)(2) Filings
  • Patent-Based and Non-Patent Based Exclusivities
  • Patent Certifications
  • Paragraph IV Patent Certifications
  • Reference Listed Drug (RLD)
  • ANDAs Containing a Paragraph IV Certification
  • Patent Litigations
  • PASS-IT Recommendations: Best Practices

About the Intended Attendee(s)

  • CEOs
  • VPs
  • Regulatory Affairs
  • Scientists
  • Engineers
  • Healthcare Professionals
  • Consultants
  • Legal Counsel
  • 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. 

Registration Options

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 3 attendees): $599 

LIVE (≥ 4 attendees): $799 

LIVE & Recorded$399 

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Mar
15
Fri
Understanding ANDAs and Paragraph IV Patent Certifications
Mar 15 @ 1:00 PM – 2:00 PM

LIVE Online Seminar

Understanding ANDAs and Paragraph IV Patent Certifications

  • Date: December 9 , 2016
  • Time: 10:00 AM PST | 01:00 PM EST
  • Duration: 60 Minutes

About the Seminar

The regulatory requirements for generic drugs include, but not limited to, same active ingredients, same dosage form, same route of administration,  same strength, and same conditions of use compared to brand name drug product (RLD: reference listed drug).

In 1984, the Drug Price Competition and Patent Term Restoration Act (P.L. 98-417), was signed into law, which is now called “the Hatch-Waxman Act.”  The Hatch-Waxman Act is intended to expedite and streamline FDA drug review and approvals for generic drugs including and patent litigation involving generic drugs.

According to the Hatch-Waxman Act, generic drug firms can file either one of two applications to obtain FDA approval of a generic drug: 1).  An Abbreviated New Drug Application (ANDA); 2). 505(b)(2) Application. Under the Hatch-Waxman Act, there are certain market exclusivity periods for NDAs (non-patent based and patent based).

New chemical entity (NCE) exclusivity (5 years) is non-patent based.  A generic drug firm is barred from filing an ANDA due to NCE exclusivity (5 years from the first NDA approval). However, a generic drug firm may file an ANDA with a Paragraph IV patent certification pursuant to the Hatch-Waxman Act, allowing a generic drug firm to challenge a brand name drug firm’s patent exclusivity for the RLD.

This seminar is intended to help industry better understand ANDA process. In particular, it is further intended to cover Paragraphs 1-4 certifications with major focus on Paragraph IV certifications.

At the end of this seminar, you should be able to understand regulatory requirements for ANDA filings with focus on paragraph IV (para IV) certifications.  

About the Areas to Be Discussed

  • Laws and Regulations
  • Definition
  • Hatch-Waxman Act
  • Orange Book
  • Regulatory Requirements for Generic ANDA and 505(b)(2) Filings
  • Patent-Based and Non-Patent Based Exclusivities
  • Patent Certifications
  • Paragraph IV Patent Certifications
  • Reference Listed Drug (RLD)
  • ANDAs Containing a Paragraph IV Certification
  • Patent Litigations
  • PASS-IT Recommendations: Best Practices

About the Intended Attendee(s)

  • CEOs
  • VPs
  • Regulatory Affairs
  • Scientists
  • Engineers
  • Healthcare Professionals
  • Consultants
  • Legal Counsel
  • 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. 

Registration Options

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 3 attendees): $599 

LIVE (≥ 4 attendees): $799 

LIVE & Recorded$399 

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Apr
1
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Apr 1 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

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Apr
3
Wed
FDA Pre-Submission and 510k Best Practices
Apr 3 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

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

  • Date: April 3, 2019
  • 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 

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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 
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Apr
9
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Apr 9 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

CE Mark: Content and Format for a Technical File and Design Dossier

  • Date: April 9, 2019
  • NOTE: This seminar recurrs tri-monthly (every 3 month) on 2nd Tuesdays.
  • 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
EU 27 Flags
CE Mark

About the Seminar

This seminar is intended to help you get familiar with regulatory requirements for CE marking for medical devices in European Union (EU) including European Economic Area (EEA). In EU and EEA, medical devices are governed by three directives (medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs)).  In particular, this seminar is further intended to discuss content and format for both a technical file (Summary Technical Documentation, STED) and design dossier for CE marking purposes in a PASS-IT manner*.

*: It refers to “Practical, Actionable, and Sustainable Solutions or Strategy in an Integrated, Thorough” or (“PASS-IT”) manner.

In this seminar, you will become familiar with how to put together a technical file or design dossier for CE marking for medical devices including IVDs. This seminar will help device firms save an enormous amount of time, efforts and resources, bringing medical products into the EU market faster.

About the Areas to Be Discussed

  • Applicable Laws, Regulations and Definitions
  • Update on New Legislation, Current Trends and Impact
  • Overview of Council Directives Concerning Medical Devices (MDD), Active Implantable Medical Devices (AIMDD), and In Vitro Diagnostic Medical Devices (IVDD)
  • CE Mark Process: CAs, NBs and EU Databases
  • Device Classification and Rules
  • Essential Requirements
  • Identifying Regulatory Requirements: Major Changes in 2014
  • How to Meet the Essential Requirements
  • Design Control
  • Verification and/or Validation
  • Risk Management to Better Meet the Essential Requirements in Addition to EN ISO 14971:2012
  • EN ISO 13485:2012
  • ISO 14155
  • Quality Management Systems and Changes Effective for Own Brand Labelling
  • Label, Labeling, and National Requirements
  • Content and Format for a Technical File (STED)
  • Contents and Format for a Design Dossier
  • Integrating a Unique Device Identification (UDI) System with Improved Awareness
  • Good Practices: Tips and Suggestions for Unannounced Audits
  • Conclusion

About the Intended Attendee(s)

  • Regulatory Affairs
  • R & D
  • Clinical Affairs
  • Quality
  • Consultants
  • Marketing
  • Legal and Compliance Officers
  • Executive Management
  • Anyone Interested in the CE Marking Process

About the Seminar Speaker

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

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

Recently, Dr. Lim developed 510(k) templates ready for 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 recently authored the Chapter 22 Postmarket Requirements in the Book entitled “Fundamentals of Global Regulatory Affairs, ” published by the Regulatory Affairs Professional Society (RAPS).  Dr. Lim also is an author for the RAPS’ online class for EU medical device regulations.  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
Apr
12
Fri
LIVE 510k Webinar
Apr 12 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

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

  • Date: April 12, 2019
  • 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 

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May
1
Wed
FDA Pre-Submission and 510k Best Practices
May 1 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

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

  • Date: April 3, 2019
  • 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 

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May
6
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
May 6 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

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