Instructor :
Charles H. Paul

Webinar ID:
11167

Has your team ever felt blindsided by an FDA inspection’s findings?

Many face challenges that go beyond standard compliance, affecting business stability and reputation. Navigating the intricate landscape of FDA regulations is more crucial than ever.

Join our 6-Hour Virtual Seminar with industry expert Charles H. Paul, as we guide you through the crucial phases of preparing for, conducting, and executing an FDA audit of your operations.

This seminar is designed to empower you with the knowledge and strategies essential for a successful FDA inspection, tailored for compliance officers, QA managers, and operational directors.

Seminar Structure:

• Phase One: Introduction to FDA Inspections
  • Understand the basics of the inspection – who, what, and when.
  • Gain insights into the FDA’s expectations and preparatory measures.
• Phase Two: Mastering the Inspection Process
  • Dive deep into the how of the inspection from both the FDA’s perspective and that of your company.
  • Learn the nuances of interacting with FDA inspectors and managing the flow of information.

Key Learning Outcomes:

• • Truthfulness and Integrity: Emphasis on the importance of truthfulness in daily operations, regulatory documentation, and direct interactions with FDA inspectors.
  • Communication Skills: Enhance your ability to handle interpersonal exchanges during inspections. Learn how to present information effectively and respond to queries without escalating issues.
  • Handling Adverse Findings: Strategies to address and mitigate adverse findings promptly during the audit process to minimize impact.
  • Inspector Techniques: Insight into the tactics and techniques used by inspectors to elicit information and how to respond appropriately to maintain a favorable position.

By the end of this seminar, you will be equipped with the critical skills and best practices to handle FDA audits confidently and efficiently.

Whether you’re looking to shore up your existing knowledge or prepare for upcoming inspections, this seminar offers valuable insights into maintaining compliance and ensuring a smooth audit process.

Enroll Now!

Has your team ever felt blindsided by an FDA inspection’s findings?

Many face challenges that go beyond standard compliance, affecting business stability and reputation. Navigating the intricate landscape of FDA regulations is more crucial than ever.

Join our 6-Hour Virtual Seminar with industry expert Charles H. Paul, as we guide you through the crucial phases of preparing for, conducting, and executing an FDA audit of your operations.

This seminar is designed to empower you with the knowledge and strategies essential for a successful FDA inspection, tailored for compliance officers, QA managers, and operational directors.

Seminar Structure:

• Phase One: Introduction to FDA Inspections
  • Understand the basics of the inspection – who, what, and when.
  • Gain insights into the FDA’s expectations and preparatory measures.
• Phase Two: Mastering the Inspection Process
  • Dive deep into the how of the inspection from both the FDA’s perspective and that of your company.
  • Learn the nuances of interacting with FDA inspectors and managing the flow of information.

Key Learning Outcomes:

• • Truthfulness and Integrity: Emphasis on the importance of truthfulness in daily operations, regulatory documentation, and direct interactions with FDA inspectors.
  • Communication Skills: Enhance your ability to handle interpersonal exchanges during inspections. Learn how to present information effectively and respond to queries without escalating issues.
  • Handling Adverse Findings: Strategies to address and mitigate adverse findings promptly during the audit process to minimize impact.
  • Inspector Techniques: Insight into the tactics and techniques used by inspectors to elicit information and how to respond appropriately to maintain a favorable position.

By the end of this seminar, you will be equipped with the critical skills and best practices to handle FDA audits confidently and efficiently.

Whether you’re looking to shore up your existing knowledge or prepare for upcoming inspections, this seminar offers valuable insights into maintaining compliance and ensuring a smooth audit process.

Enroll Now!

If you operate within a regulated industry—such as pharmaceuticals or medical devices—an FDA inspection is not just a possibility, but a certainty.

The Food, Drug, and Cosmetic Act mandates that registered domestic drug establishments be inspected by the FDA at least once every two years. Depending on the inspection type and specific circumstances, these inspections may occur even more frequently.

The outcomes of these inspections can have profound effects on your business—even if your team has followed every rule to the letter.

The way you and your colleagues interact with FDA inspectors can significantly influence the results of these inspections. Interacting effectively with inspectors isn’t instinctive; it requires specific skills and knowledge that need to be learned and honed.

Attending this webinar will equip you with:

• • Strategic insights into the FDA’s inspection process and what inspectors look for.
  • Practical techniques for engaging with inspectors to foster positive outcomes.
  • Proactive approaches to manage and mitigate any adverse findings during an inspection.

This webinar is an indispensable resource for ensuring your operations remain compliant and are represented accurately during FDA audits. Learn how to navigate these crucial interactions smoothly and professionally.

Join Now!

If you operate within a regulated industry—such as pharmaceuticals or medical devices—an FDA inspection is not just a possibility, but a certainty.

The Food, Drug, and Cosmetic Act mandates that registered domestic drug establishments be inspected by the FDA at least once every two years. Depending on the inspection type and specific circumstances, these inspections may occur even more frequently.

The outcomes of these inspections can have profound effects on your business—even if your team has followed every rule to the letter.

The way you and your colleagues interact with FDA inspectors can significantly influence the results of these inspections. Interacting effectively with inspectors isn’t instinctive; it requires specific skills and knowledge that need to be learned and honed.

Attending this webinar will equip you with:

• • Strategic insights into the FDA’s inspection process and what inspectors look for.
  • Practical techniques for engaging with inspectors to foster positive outcomes.
  • Proactive approaches to manage and mitigate any adverse findings during an inspection.

This webinar is an indispensable resource for ensuring your operations remain compliant and are represented accurately during FDA audits. Learn how to navigate these crucial interactions smoothly and professionally.

Join Now!

I. Understanding The Inspection Framework

• FDA Inspection Operations – How They Do It
  • Risk-Based Approaches For Prioritizing Sites For GMP Inspection
  • ICH Q9/Q10 Guidelines
• Types Of Inspections
  • Pre-Approval
  • Post-Approval
  • Product Surveillance
  • For Cause
• What Gets Inspected?
  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Current Good Manufacturing Practice (cGMP)
• Who Gets Inspected?
• The Systems-Based Approach
• Inspectional Trends
• Enforcement
• Inspection Considerations
  • Medical Devices
  • Drug Production
  • Clinical Trials

II. Preparation And Conduct Of Inspection

• Preparation For The Inspection
  • General Preparation Strategies
    • The 3I Approach: Implement, Inspect, Incorporate
    • Gap Analysis And Root Cause Determination
  • Specific Preparations For GCP, GLP, And cGMP
• Understanding The FDA Investigator
  • Inside The Mind Of An FDA Investigator
  • General FDA Inspection Protocol
• Conduct During The Inspection
  • Importance Of Truthfulness, Knowledgeability, And Confidence
  • Techniques FDA Uses To Elicit Information
  • The Role And Importance Of Documentation
  • Effective Communication Skills During Inspection
  • Handling Adverse Findings During The Inspection
• Inspection Do’s And Don’ts
  • Encouraged And Discouraged Behaviors
  • Critical Phrases Never To Say
  • How To Argue And Challenge Findings Appropriately

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

I. Understanding The Inspection Framework

• FDA Inspection Operations – How They Do It
  • Risk-Based Approaches For Prioritizing Sites For GMP Inspection
  • ICH Q9/Q10 Guidelines
• Types Of Inspections
  • Pre-Approval
  • Post-Approval
  • Product Surveillance
  • For Cause
• What Gets Inspected?
  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Current Good Manufacturing Practice (cGMP)
• Who Gets Inspected?
• The Systems-Based Approach
• Inspectional Trends
• Enforcement
• Inspection Considerations
  • Medical Devices
  • Drug Production
  • Clinical Trials

II. Preparation And Conduct Of Inspection

• Preparation For The Inspection
  • General Preparation Strategies
    • The 3I Approach: Implement, Inspect, Incorporate
    • Gap Analysis And Root Cause Determination
  • Specific Preparations For GCP, GLP, And cGMP
• Understanding The FDA Investigator
  • Inside The Mind Of An FDA Investigator
  • General FDA Inspection Protocol
• Conduct During The Inspection
  • Importance Of Truthfulness, Knowledgeability, And Confidence
  • Techniques FDA Uses To Elicit Information
  • The Role And Importance Of Documentation
  • Effective Communication Skills During Inspection
  • Handling Adverse Findings During The Inspection
• Inspection Do’s And Don’ts
  • Encouraged And Discouraged Behaviors
  • Critical Phrases Never To Say
  • How To Argue And Challenge Findings Appropriately

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

Maximize The Learning Experience in A Group Setting!

• Quality Assurance Managers
• Regulatory Affairs Specialists
• Compliance Officers
• Quality Control Technicians
• Risk Managers
• Production Managers
• R&D Engineers.
• Medical Device Engineers
• Operations Managers
• Clinical Research Managers
• Project Managers
• Process Improvement Specialists

Maximize The Learning Experience in A Group Setting!

• Quality Assurance Managers
• Regulatory Affairs Specialists
• Compliance Officers
• Quality Control Technicians
• Risk Managers
• Production Managers
• R&D Engineers.
• Medical Device Engineers
• Operations Managers
• Clinical Research Managers
• Project Managers
• Process Improvement Specialists