Share
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

Share
May
9
Thu
Implementing Medical Device Complaint Handling Systems
May 9 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

Implementing Medical Device Complaint Handling Systems

  • Date: May 9, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Thursdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes

About the Seminar

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

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

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

About the Areas to Be Discussed

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

About the Intended Attendee(s)

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

About the Seminar Speaker

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

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Complaint Handing and Medical Device Reporting
May 9 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Title: Complaint Handling and Medical Device Reporting (MDR)

  • Date: May 9, 2019
  • This seminar recurs tri-monthly on second Thursdays.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes

Complaint and MDR

About the Seminar

As a domestic or foreign medical device manufacturer including an importer and user facility, you are subject to regulatory requirements for complaint handling and medical device reporting (MDR) in the US.

FDA frequently cites in 483s upon establishment inspections and subsequently warning letters issued to the firms as follows.

…Your failure to establish and maintain adequate complaint handling or medical device reporting procedures…”

This presentation is intended to help global medical device firms and stakeholders adequately implement US FDA-compliant medical device complaint handling and medical device reporting (MDR) systems.  Even if it is believed that the similar or relevant procedures have been implemented in your firms, it is time to ensure all aspects of the requirements are under check to be adequate and compliant. To achieve compliance and to remain compliant with the FDA-compliant complaint handling and medical device reporting, it is imperative that the firms accurately understand, interpret, and implement the requirements for handling all complaints (electronic, written, or ORAL) and medical device reporting to be better sustainable as evident from a recent case.  

In this 60-min presentation, the speaker will guide you through the details of the required elements to successfully implement the medical device complaint handling and medical device reporting systems so that you can ensure your firms adequately establish and maintain the applicable systems in a PASS-IT manner.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations
  2. Definitions
  3. Requirements for Complaint Handling
  4. Requirements for Medical Device Reporting
  5. Applicable Processes and Procedures
  6. Key Elements in the Procedures: Complaint Handling and MDR
  7. What to Do When a Complaint Is Received
  8. What/How/When to Investigate a Complaint
  9. Complaints Investigation and Documentation
  10. Medical Device Reporting
  11. How to Determine Reportable Events
  12. Establishing Reportability Criteria
  13. Additional Documentation Requirements for MDR
  14. Mistakes and How to Avoid Mistakes and 483s
  15. Relationships between Complaint Handling, MDR, and CAPA
  16. Enforcement Case Studies
  17. Improving Our Awareness and Continuous Improvement
  18. Speaker’s PASS-IT suggestions and recommendations

About the Intended Attendee(s)

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

About the Seminar Speaker

Dr. David Lim | Complaint/MDR Speaker

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

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$299 

Share
Jun
3
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Jun 3 all-day

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

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

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

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

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

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

Purchase Options

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

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

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

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

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

Share
Jul
1
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Jul 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

Share
Jul
11
Thu
Implementing Medical Device Complaint Handling Systems
Jul 11 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

Implementing Medical Device Complaint Handling Systems

  • Date: May 9, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Thursdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes

About the Seminar

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

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

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

About the Areas to Be Discussed

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

About the Intended Attendee(s)

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

About the Seminar Speaker

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

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Aug
5
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Aug 5 all-day

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

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

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

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

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

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

Purchase Options

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

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

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

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

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

Share
Aug
8
Thu
Complaint Handing and Medical Device Reporting
Aug 8 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Title: Complaint Handling and Medical Device Reporting (MDR)

  • Date: May 9, 2019
  • This seminar recurs tri-monthly on second Thursdays.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes

Complaint and MDR

About the Seminar

As a domestic or foreign medical device manufacturer including an importer and user facility, you are subject to regulatory requirements for complaint handling and medical device reporting (MDR) in the US.

FDA frequently cites in 483s upon establishment inspections and subsequently warning letters issued to the firms as follows.

…Your failure to establish and maintain adequate complaint handling or medical device reporting procedures…”

This presentation is intended to help global medical device firms and stakeholders adequately implement US FDA-compliant medical device complaint handling and medical device reporting (MDR) systems.  Even if it is believed that the similar or relevant procedures have been implemented in your firms, it is time to ensure all aspects of the requirements are under check to be adequate and compliant. To achieve compliance and to remain compliant with the FDA-compliant complaint handling and medical device reporting, it is imperative that the firms accurately understand, interpret, and implement the requirements for handling all complaints (electronic, written, or ORAL) and medical device reporting to be better sustainable as evident from a recent case.  

In this 60-min presentation, the speaker will guide you through the details of the required elements to successfully implement the medical device complaint handling and medical device reporting systems so that you can ensure your firms adequately establish and maintain the applicable systems in a PASS-IT manner.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations
  2. Definitions
  3. Requirements for Complaint Handling
  4. Requirements for Medical Device Reporting
  5. Applicable Processes and Procedures
  6. Key Elements in the Procedures: Complaint Handling and MDR
  7. What to Do When a Complaint Is Received
  8. What/How/When to Investigate a Complaint
  9. Complaints Investigation and Documentation
  10. Medical Device Reporting
  11. How to Determine Reportable Events
  12. Establishing Reportability Criteria
  13. Additional Documentation Requirements for MDR
  14. Mistakes and How to Avoid Mistakes and 483s
  15. Relationships between Complaint Handling, MDR, and CAPA
  16. Enforcement Case Studies
  17. Improving Our Awareness and Continuous Improvement
  18. Speaker’s PASS-IT suggestions and recommendations

About the Intended Attendee(s)

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

About the Seminar Speaker

Dr. David Lim | Complaint/MDR Speaker

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

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$299 

Share
Sep
2
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Sep 2 all-day

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

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

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

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

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

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

Purchase Options

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

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

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

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

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

Share
Sep
12
Thu
Implementing Medical Device Complaint Handling Systems
Sep 12 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

Implementing Medical Device Complaint Handling Systems

  • Date: May 9, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Thursdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes

About the Seminar

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

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

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

About the Areas to Be Discussed

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

About the Intended Attendee(s)

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

About the Seminar Speaker

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

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share