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

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

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

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

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

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

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

Purchase Options

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

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

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

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

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

Share
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
May 6 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

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

  • Date: May 6, 2019
  • 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
May
7
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
May 7 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

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

  • Date: May 6, 2019
  • 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
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
May
10
Fri
Developing and Implementing a Global Regulatory Plan and Strategy
May 10 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Developing and Implementing a Global Regulatory Plan and Strategy

  • Date: May 10, 2019
  • 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
May
13
Mon
FDA Inspection Preparation and Readiness
May 13 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

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

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

About the Seminar

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

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

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

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

About the Areas to Be Discussed

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

About the Intended Attendee(s)

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

About the Seminar Speaker

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

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

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$349 

Share
Jun
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
Jun
12
Wed
Demystifying Design Control Including DHF DHR and DMR
Jun 12 @ 4:00 PM – 5:00 PM

LIVE Seminar Online

Demystifying Design Control: Design History File (DHF), Device History Record (DHR), and Device Master Record (DMR)

  • Date: June 12, 2019
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Wednesdays.
  • 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 Minutes

Design Control

About the Seminar   

Each manufacturer of any class III or class II device, and the some class I devices shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

This presentation is intended to help you understand and adequately implement Medical Device Design Control for manufacturers and relevant stakeholders. In particular, this seminar will discuss the meaning and scope of Design History File (DHF), Device History Record (DHR), Device Master Record (DMR), and relationship between them in detail.

Design control is a subsystem of the quality management systems. Design control involves an interrelated set of practices and procedures that are incorporated into the design and development process (i.e., a system of checks and balances). Design control offers improved visibility of the design (development) process to the designers and managers.

The value of an adequate design control system includes, but is not limited to, a baseline to review the system at adequate intervals for improvements based on design history, problems, and failures of the design control system. However, in practice, an adequate documentation for DHF, DHR, and DMR has been undervalued, thereby leading to 483s and FDA warning letters. Recently, FDA issued a warning letter to a device manufacturer for design changes made to FDA cleared 510(k)s without submitting a 510(k).  Accordingly, it is imperative that device firms implement an adequate design control system.

In this 60-min presentation, seminar speaker will guide you through the details of the necessary elements in the design control systems including, DHF, DHR, and DMR.

About the Areas to Be Discussed

  • Applicable Statute(s) and Regulations
  • Definitions
  • Design and Development Planning
  • Design Input
  • Design Output
  • Design Review
  • Design Verification And Validation including Software Validation
  • Design Transfer
  • Design Changes
  • Design History File (DHF)
  • Device History Record (DHR)
  • Device Master Record (DMR)
  • Common Pitfalls (Failure to Adequately Implement Design Control)
  • How to Avoid Compliance Concerns and Non-Conformity
  • Enforcement Actions: Case Studies
  • PASS-IT Suggestions/Recommendations

About the Intended Attendee(s)

  • R&D Scientists and Engineers, Managers, Directors, and VPs
  • Regulatory Affairs
  • Quality
  • Clinical Affairs
  • Consultants
  • Contractors
  • Compliance Officers
  • Senior Management
  • Anyone Interested in the Subject

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

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Jul
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

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