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Oct
1
Mon
Implementing Global Medical Device Adverse Event Reporting Systems
Oct 1 @ 2:00 PM – 3:00 PM

LIVE Seminar Online

Implementing Global Medical Device Adverse Event Reporting (AER) Systems in EU, Canada and US

  • Date: July 10, 2017
  • NOTE: This seminar recurrs tri-monthly (every three 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 | 02:00 PM EST
  • Duration: 60 Minutes

Globe

About the Seminar

This presentation is intended to greatly help global medical device firms implement the global medical device adverse event (AER) reporting systems in EU, Canada, and US.  Even if similar or relevant procedures have been implemented in your firms, it is time to ensure the relevant requirements are under check. To achieve compliance and remain compliant with the global adverse event reporting requirements, it is critical to accurately interpret and understand what requirements apply and how to meet the said requirements.

In this 60-min presentation, the speaker will guide you through the details of the required elements in implementing the global medical device adverse event reporting systems in EU, Canada and US.

About the Areas to Be Discussed

  1. Applicable laws and regulations in EU, Canada, and US
  2. Definitions
  3. Guidance documents-relevant and applicable
  4. Adverse event reporting requirements in EU, Canada, and US
  5. Surveillance and vigilance systems in EU
  6. Mandatory medical device problem reporting requirements in Canada
  7. Mandatory medical device reporting (MDR) requirements in US
  8. Reporting template forms to review
  9. Speaker’s practical tips and cases

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

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, 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 the FDA News. Dr. Lim also contributes to FDA Doctor and FDA Guidance Net.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

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Oct
2
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
Oct 2 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

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

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

About the Seminar

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

About the Areas to Be Discussed

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

About the Intended Attendee(s)

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

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

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

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

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Oct
8
Mon
FDA Inspection Preparation and Readiness
Oct 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 

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Oct
12
Fri
Developing and Implementing a Global Regulatory Plan and Strategy
Oct 12 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Developing and Implementing a Global Regulatory Plan and Strategy

  • Date: April 13, 2018
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 MinutesCompass

About the Seminar

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

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

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

About the Areas to Be Discussed

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

About the Intended Attendee(s)

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

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

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

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$349 

 

Share
Dec
4
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
Dec 4 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

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

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

About the Seminar

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

About the Areas to Be Discussed

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

About the Intended Attendee(s)

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

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

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

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Dec
10
Mon
FDA Inspection Preparation and Readiness
Dec 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
Dec
11
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Dec 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
Dec
13
Thu
Complaint Handing and Medical Device Reporting
Dec 13 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Title: Complaint Handling and Medical Device Reporting (MDR)

  • Date: December 8, 2016
  • 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 

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Dec
14
Fri
Medical Device Laws and Regulations in Asian Countries
Dec 14 @ 11:00 AM – 12:00 PM

LIVE Online Seminar

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

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

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

About the Seminar

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

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

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

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

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

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

About the Areas to Be Discussed

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

About the Intended Attendee(s)

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

About the Seminar Speaker

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

Registration Options

LIVE (one attendee): $249 

Recorded$299 

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LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$349 

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Developing and Implementing a Global Regulatory Plan and Strategy
Dec 14 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Developing and Implementing a Global Regulatory Plan and Strategy

  • Date: April 13, 2018
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 MinutesCompass

About the Seminar

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

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

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

About the Areas to Be Discussed

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

About the Intended Attendee(s)

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

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

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

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$349 

 

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