Share
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 

Share
May
13
Mon
FDA Inspection Preparation and Readiness
May 13 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

FDA Inspection Preparation and Readiness: the Top 20 Most Common GMP Deficiencies for Device Manufacturers

  • Date: May 13, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Mondays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 11:00 AM PST | 2:00 PM EST
  • Duration: 60 Minutes

About the Seminar

This seminar is intended to discuss FDA inspection practices and the most common deficiencies for medical device manufacturers including in vitro diagnostic device manufacturers. This presentation is further intended to help you prepare for and manage an FDA inspection in a proactive and effective manner. The top twenty (20) common deficiencies are based on the speaker’s analysis of 483s issued for the past seven (8) years.

The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.

This presentation will provide great opportunities to become familiar with the FDA inspection practices and the most common top twenty (20) deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.

The speaker will share his PASS-IT recommendation/suggestions.

About the Areas to Be Discussed

  1. Applicable Laws and Regulation
  2. FDA Manuals and Inspection Guides
  3. Hosting an FDA Inspection
  4. Field Management Directives
  5. Inspection Types and Categories
  6. Inspection Classification
  7. FDA Forms 482 and 483
  8. Top Twenty (20) Most Common Deficiencies During FDA Inspections for Device Manufacturers
  9. How to Identify Gaps between FDA Expectations and Firms’ Current Level of Compliance
  10. What/How to Prepare for and Manage an FDA Inspection
  11. How to Communicate Before, During and After inspection: Dos and Don’ts
  12. Common Mistakes and How to Prevent Them
  13. How to Most Effectively Use Close Out Meeting
  14. Responding to 483s, If Issued
  15. How to Communicate with Emotional Intelligence
  16. Employee Training
  17. Actual FDA Inspection Case Studies (Reports)
  18. Speaker’s PASS-IT Suggestions/Recommendations
  19. Conclusion

About the Intended Attendee(s)

  • Quality
  • Manufacturing
  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Senior Management
  • Consultants
  • Contractors
  • Compliance Officers
  • Anyone Interested in the FDA Inspection

About the Seminar Speaker

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

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past 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.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$349 

Share
Jun
5
Wed
FDA Pre-Submission and 510k Best Practices
Jun 5 @ 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 

Share
Jun
20
Thu
FDA 510k Best Practices
Jun 20 @ 3:00 PM – 4:00 PM

LIVE Seminar Online

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

  • Date: June 20, 2019
  • 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 

Share
Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820
Jun 20 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820

  • Date: June 20, 2019
  • NOTE: This seminar recurrs tri-monthly (every three month) on 3rd 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

Seminar with Quality, Effectiveness, Satisfaction and SuccessThis online seminar (webinar) is intended to help you get familiar with how to establish an internal audit program of the quality management systems (QMS) for medical device manufacturers in preparation for an FDA inspection under 21 CFR Part 820 or for those who are subject to ISO 13485.

This webinar is also intended to greatly increase your awareness and familiarity with process-based approaches to internal auditing of quality management system requirements including FDA regulations affecting quality records and FDA’s policy on the reports required by the following regulations.

  • 21 CFR 820.20(c) Management review
  • 21 CFR 820.22 Quality audits, and supplier audit reports
  • 21 CFR 820.50(a) Evaluation of suppliers, contractors, and consultants

At the end of the webinar, you will become familiar with the regulatory requirements for establishing an adequate internal audit program while bringing benefits and opportunities to greatly improve your quality management systems and to further save an enormous amount of resources pursuant to ISO 13485 and 21 CFR Part 820.

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.

About the Areas to Be Discussed

  • Statutes and Regulations
  • Definitions
  • ISO 13485 and 21 CFR Part 820 (QSR)
  • Auditing Strategy, Objectives, Planning, Frequency, Duration and Logistics
  • How to Audit Quality Management Systems
  • Various Audit Approaches
  • Quality Systems and Subsystems in ISO 13485
  • Quality Systems and Subsystems under 21 CFR Part 820
  • Comparative Overview of both ISO 13485 and 21 CFR Part 820
  • FDA Regulations (21 CFR Part 11 and 21 CFR 820.180) and FDA Policy on Audit Reports
  • Good Practices: Speaker’s Suggestions and Recommendations
  • Instructor’s unique regulatory guide to provide practical, actionable and sustainable solutions in an integrated, through (PASS-IT) manner.

About the Intended Attendee(s)

  • Professionals from Quality, Regulatory Affairs, R&D, and Clinical Affairs
  • 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 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 published by FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$349 

Share
Jul
3
Wed
FDA Pre-Submission and 510k Best Practices
Jul 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 

Share
Jul
8
Mon
FDA Inspection Preparation and Readiness
Jul 8 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

FDA Inspection Preparation and Readiness: the Top 20 Most Common GMP Deficiencies for Device Manufacturers

  • Date: May 13, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Mondays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 11:00 AM PST | 2:00 PM EST
  • Duration: 60 Minutes

About the Seminar

This seminar is intended to discuss FDA inspection practices and the most common deficiencies for medical device manufacturers including in vitro diagnostic device manufacturers. This presentation is further intended to help you prepare for and manage an FDA inspection in a proactive and effective manner. The top twenty (20) common deficiencies are based on the speaker’s analysis of 483s issued for the past seven (8) years.

The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.

This presentation will provide great opportunities to become familiar with the FDA inspection practices and the most common top twenty (20) deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.

The speaker will share his PASS-IT recommendation/suggestions.

About the Areas to Be Discussed

  1. Applicable Laws and Regulation
  2. FDA Manuals and Inspection Guides
  3. Hosting an FDA Inspection
  4. Field Management Directives
  5. Inspection Types and Categories
  6. Inspection Classification
  7. FDA Forms 482 and 483
  8. Top Twenty (20) Most Common Deficiencies During FDA Inspections for Device Manufacturers
  9. How to Identify Gaps between FDA Expectations and Firms’ Current Level of Compliance
  10. What/How to Prepare for and Manage an FDA Inspection
  11. How to Communicate Before, During and After inspection: Dos and Don’ts
  12. Common Mistakes and How to Prevent Them
  13. How to Most Effectively Use Close Out Meeting
  14. Responding to 483s, If Issued
  15. How to Communicate with Emotional Intelligence
  16. Employee Training
  17. Actual FDA Inspection Case Studies (Reports)
  18. Speaker’s PASS-IT Suggestions/Recommendations
  19. Conclusion

About the Intended Attendee(s)

  • Quality
  • Manufacturing
  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Senior Management
  • Consultants
  • Contractors
  • Compliance Officers
  • Anyone Interested in the FDA Inspection

About the Seminar Speaker

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

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past 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.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$349 

Share
Aug
7
Wed
FDA Pre-Submission and 510k Best Practices
Aug 7 @ 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 

Share
Sep
4
Wed
FDA Pre-Submission and 510k Best Practices
Sep 4 @ 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 

Share
Sep
9
Mon
FDA Inspection Preparation and Readiness
Sep 9 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

FDA Inspection Preparation and Readiness: the Top 20 Most Common GMP Deficiencies for Device Manufacturers

  • Date: May 13, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Mondays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 11:00 AM PST | 2:00 PM EST
  • Duration: 60 Minutes

About the Seminar

This seminar is intended to discuss FDA inspection practices and the most common deficiencies for medical device manufacturers including in vitro diagnostic device manufacturers. This presentation is further intended to help you prepare for and manage an FDA inspection in a proactive and effective manner. The top twenty (20) common deficiencies are based on the speaker’s analysis of 483s issued for the past seven (8) years.

The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.

This presentation will provide great opportunities to become familiar with the FDA inspection practices and the most common top twenty (20) deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.

The speaker will share his PASS-IT recommendation/suggestions.

About the Areas to Be Discussed

  1. Applicable Laws and Regulation
  2. FDA Manuals and Inspection Guides
  3. Hosting an FDA Inspection
  4. Field Management Directives
  5. Inspection Types and Categories
  6. Inspection Classification
  7. FDA Forms 482 and 483
  8. Top Twenty (20) Most Common Deficiencies During FDA Inspections for Device Manufacturers
  9. How to Identify Gaps between FDA Expectations and Firms’ Current Level of Compliance
  10. What/How to Prepare for and Manage an FDA Inspection
  11. How to Communicate Before, During and After inspection: Dos and Don’ts
  12. Common Mistakes and How to Prevent Them
  13. How to Most Effectively Use Close Out Meeting
  14. Responding to 483s, If Issued
  15. How to Communicate with Emotional Intelligence
  16. Employee Training
  17. Actual FDA Inspection Case Studies (Reports)
  18. Speaker’s PASS-IT Suggestions/Recommendations
  19. Conclusion

About the Intended Attendee(s)

  • Quality
  • Manufacturing
  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Senior Management
  • Consultants
  • Contractors
  • Compliance Officers
  • Anyone Interested in the FDA Inspection

About the Seminar Speaker

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

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past 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.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$349 

Share