Share
Mar
12
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Mar 12 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

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

  • Date: June 13, 2017
  • 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
Mar
21
Thu
Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820
Mar 21 @ 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 15, 2017
  • 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
Apr
8
Mon
FDA Inspection Preparation and Readiness
Apr 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: June 12, 2017
  • 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
10
Mon
FDA Inspection Preparation and Readiness
Jun 10 @ 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: June 12, 2017
  • 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
11
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Jun 11 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

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

  • Date: June 13, 2017
  • 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
Jun
20
Thu
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 15, 2017
  • 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
Aug
12
Mon
FDA Inspection Preparation and Readiness
Aug 12 @ 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: June 12, 2017
  • 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
Sep
10
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Sep 10 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

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

  • Date: June 13, 2017
  • 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
Sep
19
Thu
Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820
Sep 19 @ 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 15, 2017
  • 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
Oct
14
Mon
FDA Inspection Preparation and Readiness
Oct 14 @ 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: June 12, 2017
  • 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