Instructor :
John E Lincoln

Webinar ID:
13916

In recent years, the U.S. FDA’s approach to CGMP compliance audits has undergone a significant transformation.

Driven by increased public scrutiny over issues such as medical device shortages, product recalls, and manufacturing lapses, the Agency is now placing greater emphasis on high-risk areas during inspections—especially those outlined in the Quality System Inspection Technique (QSIT).

This 6-hour virtual seminar offers a deep dive into the evolving inspection landscape for medical device manufacturers.

Participants will gain a clear understanding of how FDA investigators prepare for, conduct, and evaluate audits using critical tools like Compliance Program Guidance Manual CP 7382.845.

The training simulates a “real-world” inspection by figuratively walking attendees through a modern CGMP audit—from entry to exit—with expert insight into regulatory expectations and pitfalls.

Key highlights include:

• • FDA audit priorities and how they’ve shifted post-pandemic
  • Overview of QSIT subsystems and high-risk focus areas
  • Breakdown of inspection resources and procedures, including SOPs used by investigators
  • A “behind-the-scenes” look at how audits are conducted in actual device facilities
  • Insights on how to interpret and respond to FDA 483 observations

Designed for professionals in Quality Assurance, Regulatory Affairs, Compliance, and Manufacturing, this training equips your team to better navigate the ever-evolving regulatory climate.

Enroll Now!

In recent years, the U.S. FDA’s approach to CGMP compliance audits has undergone a significant transformation.

Driven by increased public scrutiny over issues such as medical device shortages, product recalls, and manufacturing lapses, the Agency is now placing greater emphasis on high-risk areas during inspections—especially those outlined in the Quality System Inspection Technique (QSIT).

This 6-hour virtual seminar offers a deep dive into the evolving inspection landscape for medical device manufacturers.

Participants will gain a clear understanding of how FDA investigators prepare for, conduct, and evaluate audits using critical tools like Compliance Program Guidance Manual CP 7382.845.

The training simulates a “real-world” inspection by figuratively walking attendees through a modern CGMP audit—from entry to exit—with expert insight into regulatory expectations and pitfalls.

Key highlights include:

• • FDA audit priorities and how they’ve shifted post-pandemic
  • Overview of QSIT subsystems and high-risk focus areas
  • Breakdown of inspection resources and procedures, including SOPs used by investigators
  • A “behind-the-scenes” look at how audits are conducted in actual device facilities
  • Insights on how to interpret and respond to FDA 483 observations

Designed for professionals in Quality Assurance, Regulatory Affairs, Compliance, and Manufacturing, this training equips your team to better navigate the ever-evolving regulatory climate.

Enroll Now!

FDA inspections are tougher, more targeted, and less forgiving than ever.

Traditional preparation methods no longer meet the mark—especially for small to mid-sized manufacturers that increasingly find themselves under scrutiny.

This seminar is your opportunity to stay ahead of regulatory trends and avoid costly missteps during pre- and post-market inspections.

You’ll walk away with:

• • Clear expectations of how FDA inspections are now conducted
  • Tools to anticipate high-risk focus areas before the audit begins
  • Strategies to prepare your team, documents, and facility to meet evolving standards
  • Expert insight into how investigators interpret compliance in today’s climate

Whether you’re facing your first inspection or your fiftieth, this course delivers actionable guidance that helps you stay compliant, minimize risk, and build a culture of inspection readiness across your organization.

Join Now!

FDA inspections are tougher, more targeted, and less forgiving than ever.

Traditional preparation methods no longer meet the mark—especially for small to mid-sized manufacturers that increasingly find themselves under scrutiny.

This seminar is your opportunity to stay ahead of regulatory trends and avoid costly missteps during pre- and post-market inspections.

You’ll walk away with:

• • Clear expectations of how FDA inspections are now conducted
  • Tools to anticipate high-risk focus areas before the audit begins
  • Strategies to prepare your team, documents, and facility to meet evolving standards
  • Expert insight into how investigators interpret compliance in today’s climate

Whether you’re facing your first inspection or your fiftieth, this course delivers actionable guidance that helps you stay compliant, minimize risk, and build a culture of inspection readiness across your organization.

Join Now!

1. Understanding FDA’s Quality System Requirements

• • Overview of 21 CFR Part 820
  • Key principles and core compliance elements

2. Comparative Overview of Regulatory Standards

• • Similarities and differences between 21 CFR Part 820 and ISO 13485:2016
  • Emerging trends and tougher FDA positions on compliance

3. Decoding the FDA’s Quality System Inspection Technique (QSIT)

• • Evolution of QSIT focus areas: from 15 to 7 to 4
  • What this means for your inspection strategy

4. Inside a Modern FDA CGMP Inspection

• • Step-by-step look at a typical inspection sequence
  • What investigators observe, question, and document

5. High-Risk Documentation & Records Issues

• • Common documentation pitfalls
  • Best practices for maintaining inspection-ready records

6. Design Control and Development Planning

• • Key inspection triggers related to Design Controls
  • How to document and demonstrate compliance effectively

7. Virtual Inspections and Remote Audit Trends

• • How virtual inspections are conducted
  • Preparing your digital systems and teams

8. Pre-Inspection Readiness and Strategy

• • Preparing teams, sites, and documents
  • Developing an effective inspection readiness plan

9. Responding to Inspection Notifications

• • What to do immediately upon notice of an FDA inspection
  • Setting the tone for a successful audit

10 Managing FDA Interactions During and After the Audit

• • How to communicate and respond during the inspection
  • Crafting timely and compliant responses to FDA 483 observations

BONUS:

1. 1. PDF Copy of the Presentation Handout for Your Future Reference
   2. Soft Copy of the Certificate of Completion on Request
   3. Q&A Session with the Presenter: Get Your Pressing Questions Answered Verbally, via Chat or Email

1. Understanding FDA’s Quality System Requirements

• • Overview of 21 CFR Part 820
  • Key principles and core compliance elements

2. Comparative Overview of Regulatory Standards

• • Similarities and differences between 21 CFR Part 820 and ISO 13485:2016
  • Emerging trends and tougher FDA positions on compliance

3. Decoding the FDA’s Quality System Inspection Technique (QSIT)

• • Evolution of QSIT focus areas: from 15 to 7 to 4
  • What this means for your inspection strategy

4. Inside a Modern FDA CGMP Inspection

• • Step-by-step look at a typical inspection sequence
  • What investigators observe, question, and document

5. High-Risk Documentation & Records Issues

• • Common documentation pitfalls
  • Best practices for maintaining inspection-ready records

6. Design Control and Development Planning

• • Key inspection triggers related to Design Controls
  • How to document and demonstrate compliance effectively

7. Virtual Inspections and Remote Audit Trends

• • How virtual inspections are conducted
  • Preparing your digital systems and teams

8. Pre-Inspection Readiness and Strategy

• • Preparing teams, sites, and documents
  • Developing an effective inspection readiness plan

9. Responding to Inspection Notifications

• • What to do immediately upon notice of an FDA inspection
  • Setting the tone for a successful audit

10 Managing FDA Interactions During and After the Audit

• • How to communicate and respond during the inspection
  • Crafting timely and compliant responses to FDA 483 observations

BONUS:

1. 1. PDF Copy of the Presentation Handout for Your Future Reference
   2. Soft Copy of the Certificate of Completion on Request
   3. Q&A Session with the Presenter: Get Your Pressing Questions Answered Verbally, via Chat or Email

Everybody Benefits from Watching This. Even Better When Done as a Group!

• • Quality Assurance Professionals In Medical Device Companies
  • Regulatory Affairs Specialists Managing FDA Compliance Processes
  • Compliance Officers Overseeing Inspection Readiness Programs
  • Manufacturing Managers Handling Day-To-Day Operational Quality
  • R&D Teams Involved In Design And Development
  • Supply Chain Managers Working With Regulated Components
  • Auditors And Consultants Supporting Medical Device Compliance
  • Senior Executives Responsible For Regulatory Risk Oversight

Everybody Benefits from Watching This. Even Better When Done as a Group!

• • Quality Assurance Professionals In Medical Device Companies
  • Regulatory Affairs Specialists Managing FDA Compliance Processes
  • Compliance Officers Overseeing Inspection Readiness Programs
  • Manufacturing Managers Handling Day-To-Day Operational Quality
  • R&D Teams Involved In Design And Development
  • Supply Chain Managers Working With Regulated Components
  • Auditors And Consultants Supporting Medical Device Compliance
  • Senior Executives Responsible For Regulatory Risk Oversight