Navigating FDA cGMP Regulations: Mastering 21 CFR 210, 211, and 820
Crack the Code of 21 CFR 820 and FDA Inspections!
Instructor :
John E Lincoln
Webinar ID:
11848
Date: JAN 07, 2025 (TUE)
Start Time: 10 AM PT - 11 AM PT
Duration: 1 Hr.
What will you learn
-
- Understanding U.S. FDA’s 21 CFR 820 and QSR Essentials
- Management Responsibility’s Role in Compliance and Quality Assurance
- Design Control, Risk Management, and Human Factors/Use Engineering
- Role of Risk Management File (ISO 14971) in Compliance
- Significance of Use Engineering File (IEC 62366-1)
- Production and Process Controls for Ensuring Product Quality
- CAPA Requirements for Corrective and Preventive Actions
- Essential Documentation: DHF, DMR, DHR, and ….
-
- Understanding U.S. FDA’s 21 CFR 820 and QSR Essentials
- Management Responsibility’s Role in Compliance and Quality Assurance
- Design Control, Risk Management, and Human Factors/Use Engineering
- Role of Risk Management File (ISO 14971) in Compliance
- Significance of Use Engineering File (IEC 62366-1)
- Production and Process Controls for Ensuring Product Quality
- CAPA Requirements for Corrective and Preventive Actions
- Essential Documentation: DHF, DMR, DHR, and QMS Records
- FDA Inspection and Audit Focus: Key Preparation Areas
Course Description
What are the U.S. FDA cGMP Requirements for Manufacturing Medical Devices?
This webinar provides an in-depth look at the key Quality System Regulation (QSR) requirements under 21 CFR 820.
Key Highlights:
-
- Overview of the 14 essential elements of Medical Device cGMPs outlined in 21 CFR 820.
- Detailed exploration of the 7 key elements and the 4 defining elements as evaluated by the FDA’s QSIT.
- Understanding the Product Development and Manufacturing Process (“realization”), focusing on compliance and documentation.
- Comprehensive insights into Design Control, Device History File (DHF), Device Master Record (DMR), and Device History Record (DHR).
- In-depth discussion on Corrective and Preventive Action (CAPA) requirements and their key components.
- Insights into Production and Process Control (P&PC) and their significance.
- Understanding Verification and Validation processes, including software compliance – the “Why” and “How”.
- Explore differing approaches to Compliance Inspections/Audits conducted internally and by the FDA.
This 60-minute session is tailored to help you navigate the complexities of FDA regulations, ensuring your organization’s processes are in line with current cGMP standards.
Join Now!
What are the U.S. FDA cGMP Requirements for Manufacturing Medical Devices?
This webinar provides an in-depth look at the key Quality System Regulation (QSR) requirements under 21 CFR 820.
Key Highlights:
-
- Overview of the 14 essential elements of Medical Device cGMPs outlined in 21 CFR 820.
- Detailed exploration of the 7 key elements and the 4 defining elements as evaluated by the FDA’s QSIT.
- Understanding the Product Development and Manufacturing Process (“realization”), focusing on compliance and documentation.
- Comprehensive insights into Design Control, Device History File (DHF), Device Master Record (DMR), and Device History Record (DHR).
- In-depth discussion on Corrective and Preventive Action (CAPA) requirements and their key components.
- Insights into Production and Process Control (P&PC) and their significance.
- Understanding Verification and Validation processes, including software compliance – the “Why” and “How”.
- Explore differing approaches to Compliance Inspections/Audits conducted internally and by the FDA.
This 60-minute session is tailored to help you navigate the complexities of FDA regulations, ensuring your organization’s processes are in line with current cGMP standards.
Join Now!
Why you should attend
In the rapidly evolving landscape of medical device manufacturing, compliance with FDA 21 CFR 820 is more than just a regulatory checkbox—it’s a critical component of your company’s success.
Navigating these complex regulations can be a daunting task, but failure to comply can result in serious consequences, including 483 Observations, Warning Letters, or even product recalls.
Why is this important now?
-
- The FDA is tightening its focus on Quality System Regulations, placing a stronger emphasis on risk management and human factors.
- Recent updates in FDA inspections reveal an increased scrutiny on the 4 most critical elements of the QSR, making it essential to stay ahead of compliance expectations.
- Companies face growing pressure to maintain a robust Quality Management System (QMS) that not only meets regulatory requirements but also enhances product safety and customer satisfaction.
What will you gain?
-
- Expert insights into the 15 key systems and procedures mandated by cGMPs, and a deep dive into the 7 systems prioritized by the FDA.
- A clear understanding of how to build a compliant QMS, including the interrelationship between the Risk Management File (ISO 14971) and Use Engineering File (IEC 62366-1).
- Practical strategies to address common compliance challenges, helping you avoid pitfalls that can lead to adulterated products.
- Skills to effectively prepare for FDA inspections, ensuring that your company not only passes audits but also implements a culture of continuous improvement.
Join us to empower yourself with the knowledge and tools to navigate the complexities of FDA compliance, ensuring your company’s products are safe, effective, and market-ready.
Enroll Now!
In the rapidly evolving landscape of medical device manufacturing, compliance with FDA 21 CFR 820 is more than just a regulatory checkbox—it’s a critical component of your company’s success.
Navigating these complex regulations can be a daunting task, but failure to comply can result in serious consequences, including 483 Observations, Warning Letters, or even product recalls.
Why is this important now?
-
- The FDA is tightening its focus on Quality System Regulations, placing a stronger emphasis on risk management and human factors.
- Recent updates in FDA inspections reveal an increased scrutiny on the 4 most critical elements of the QSR, making it essential to stay ahead of compliance expectations.
- Companies face growing pressure to maintain a robust Quality Management System (QMS) that not only meets regulatory requirements but also enhances product safety and customer satisfaction.
What will you gain?
-
- Expert insights into the 15 key systems and procedures mandated by cGMPs, and a deep dive into the 7 systems prioritized by the FDA.
- A clear understanding of how to build a compliant QMS, including the interrelationship between the Risk Management File (ISO 14971) and Use Engineering File (IEC 62366-1).
- Practical strategies to address common compliance challenges, helping you avoid pitfalls that can lead to adulterated products.
- Skills to effectively prepare for FDA inspections, ensuring that your company not only passes audits but also implements a culture of continuous improvement.
Join us to empower yourself with the knowledge and tools to navigate the complexities of FDA compliance, ensuring your company’s products are safe, effective, and market-ready.
Enroll Now!
Areas Covered
-
- The U.S. FDA’s 21 CFR 820, QSR, and Device cGMPs/QMS (QSIT)
- Management Responsibility and Its Impact on Compliance
- Design Control, Risk Management, and Human Factors/Use Engineering
- The Risk Management File (ISO 14971) and Its Role in Compliance
- The Use Engineering File (IEC 62366-1) and Its Significance
- Production and Process Controls for Quality Assurance
- Corrective and Preventive Action (CAPA) Requirements
- Device History File (DHF) Required Contents
- The Device Master Record (DMR) and Device History Record (DHR)
- Documentation Requirements for Regulatory Compliance
- Expected QMS Records and Their Importance
- FDA Inspection and Audit Focus: Key Areas to Prepare
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
-
- The U.S. FDA’s 21 CFR 820, QSR, and Device cGMPs/QMS (QSIT)
- Management Responsibility and Its Impact on Compliance
- Design Control, Risk Management, and Human Factors/Use Engineering
- The Risk Management File (ISO 14971) and Its Role in Compliance
- The Use Engineering File (IEC 62366-1) and Its Significance
- Production and Process Controls for Quality Assurance
- Corrective and Preventive Action (CAPA) Requirements
- Device History File (DHF) Required Contents
- The Device Master Record (DMR) and Device History Record (DHR)
- Documentation Requirements for Regulatory Compliance
- Expected QMS Records and Their Importance
- FDA Inspection and Audit Focus: Key Areas to Prepare
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Who is this course for
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Quality Assurance Manager
- Regulatory Affairs Specialist
- Compliance Officer
- Medical Device Engineer
- Quality Systems Auditor
- Production Manager
- Manufacturing Engineer
- R&D Engineer
- Quality Control Inspector
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Quality Assurance Manager
- Regulatory Affairs Specialist
- Compliance Officer
- Medical Device Engineer
- Quality Systems Auditor
- Production Manager
- Manufacturing Engineer
- R&D Engineer
- Quality Control Inspector
Instructor Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
