Instructor :
Charles H. Paul

Webinar ID:
8520

Enhance Your FDA Audit Success with Our Comprehensive Seminar!

The FDA’s increased surveillance across regulated industries emphasizes the need for companies to not only meet regulatory requirements but also to master the art of effective audits.

The way your team handles an audit and interacts with FDA inspectors can dramatically influence the outcome. A misstep in this critical interaction could have significant consequences.

Our seminar is strategically divided into two phases for optimal learning:

• Phase 1: Foundations of Inspection (Day 1, 4-hrs + Breaks)
  • Understanding the Basics: Dive into the “who,” “what,” and “when” of FDA inspections to build your foundational knowledge.
• Phase 2: Advanced Inspection Tactics (Day 2, 4-hrs + Breaks)
  • Mastering the How: Explore inspection techniques from both the FDA’s and the inspected entity’s perspectives, enhancing your preparedness and response strategies.

Key Highlights of the Seminar:

• Emphasis on Truthfulness:
  • The critical role of honesty in daily operations, regulatory documentation, and interactions with FDA inspectors.
• Navigating Inspector Techniques:
  • Uncover the tricks and tactics inspectors use to gather information. Your responses could significantly impact the audit’s outcome.
• Essential Communication Skills:
  • Learn effective communication strategies during inspections and how to engage confidently with inspectors.
• Managing Adverse Findings:
  • Strategies for addressing negative findings promptly to avoid exacerbating issues.

Empower yourself and your team with the knowledge to navigate FDA inspections successfully. Our seminar offers valuable insights and practical skills to turn potential challenges into opportunities for compliance excellence.

Join us now and pave the way for successful FDA audits!

Enhance Your FDA Audit Success with Our Comprehensive Seminar!

The FDA’s increased surveillance across regulated industries emphasizes the need for companies to not only meet regulatory requirements but also to master the art of effective audits.

The way your team handles an audit and interacts with FDA inspectors can dramatically influence the outcome. A misstep in this critical interaction could have significant consequences.

Our seminar is strategically divided into two phases for optimal learning:

• Phase 1: Foundations of Inspection (Day 1, 4-hrs + Breaks)
  • Understanding the Basics: Dive into the “who,” “what,” and “when” of FDA inspections to build your foundational knowledge.
• Phase 2: Advanced Inspection Tactics (Day 2, 4-hrs + Breaks)
  • Mastering the How: Explore inspection techniques from both the FDA’s and the inspected entity’s perspectives, enhancing your preparedness and response strategies.

Key Highlights of the Seminar:

• Emphasis on Truthfulness:
  • The critical role of honesty in daily operations, regulatory documentation, and interactions with FDA inspectors.
• Navigating Inspector Techniques:
  • Uncover the tricks and tactics inspectors use to gather information. Your responses could significantly impact the audit’s outcome.
• Essential Communication Skills:
  • Learn effective communication strategies during inspections and how to engage confidently with inspectors.
• Managing Adverse Findings:
  • Strategies for addressing negative findings promptly to avoid exacerbating issues.

Empower yourself and your team with the knowledge to navigate FDA inspections successfully. Our seminar offers valuable insights and practical skills to turn potential challenges into opportunities for compliance excellence.

Join us now and pave the way for successful FDA audits!

The fear of FDA audits often stems from uncertainty and a lack of preparedness. As regulatory scrutiny intensifies, so does the need for a clear, actionable strategy to ensure compliance and protect your organization’s reputation.

Our “FDA Audit Mastery: 2-Day Virtual Bootcamp” equips you with the knowledge and tools for seamless audit preparation:

• Navigate FDA Audits with Confidence: Organizations that prioritize thorough FDA audit preparation consistently report smoother inspections and fewer compliance challenges. Our 2-day bootcamp is designed to arm you and your team with the essential tools and techniques for effective preparation, ensuring a seamless audit experience.
• Regulatory Readiness is Key: Whether you’re in pharmaceuticals, medical devices, or any FDA-regulated industry, an inspection by the U.S. Food and Drug Administration (FDA) is inevitable. Being unprepared for an FDA audit can lead to increased regulatory scrutiny, with subsequent inspections becoming more frequent and rigorous. The goal is clear: ensure compliance to avoid the intensification of regulatory oversight.
• Protect Your Organization’s Reputation: The stakes of failing an FDA audit extend beyond immediate regulatory repercussions. Negative findings or compliance deficiencies can become public, adversely affecting your organization’s image and its commitment to quality, safety, and regulatory adherence.
• Mitigate Risks and Maintain Compliance: Proactive audit preparation is crucial. It helps safeguard against potential risks and the negative impacts on your business, ensuring ongoing compliance with regulatory standards. Remember, the Food, Drug, and Cosmetic Act mandates that “Registered domestic drug establishments shall be inspected by the FDA at least once every two years,” with the possibility of more frequent inspections depending on various factors.
• The Impact of Interactions: The dynamics of how you and your colleagues engage with FDA inspectors can significantly influence the outcomes of these inspections. Mastering effective interaction techniques is vital for steering the results toward positive conclusions.

Bootcamp Benefits:

• Learn from the Experts: Absorb insights, best practices, and actionable strategies from industry veterans who have navigated FDA audits with success.
• Stay Ahead of the Curve: Keep abreast of regulatory updates and refine your compliance strategies to mitigate the risk of non-compliance.
• Network and Collaborate: Engage with professionals across industries, share insights, and enhance your compliance efforts through collaboration.

Maximize your preparedness and position your organization for success in the face of FDA inspections. Join our bootcamp now and transform regulatory challenges into opportunities for excellence.

Enroll Today!

The fear of FDA audits often stems from uncertainty and a lack of preparedness. As regulatory scrutiny intensifies, so does the need for a clear, actionable strategy to ensure compliance and protect your organization’s reputation.

Our “FDA Audit Mastery: 2-Day Virtual Bootcamp” equips you with the knowledge and tools for seamless audit preparation:

• Navigate FDA Audits with Confidence: Organizations that prioritize thorough FDA audit preparation consistently report smoother inspections and fewer compliance challenges. Our 2-day bootcamp is designed to arm you and your team with the essential tools and techniques for effective preparation, ensuring a seamless audit experience.
• Regulatory Readiness is Key: Whether you’re in pharmaceuticals, medical devices, or any FDA-regulated industry, an inspection by the U.S. Food and Drug Administration (FDA) is inevitable. Being unprepared for an FDA audit can lead to increased regulatory scrutiny, with subsequent inspections becoming more frequent and rigorous. The goal is clear: ensure compliance to avoid the intensification of regulatory oversight.
• Protect Your Organization’s Reputation: The stakes of failing an FDA audit extend beyond immediate regulatory repercussions. Negative findings or compliance deficiencies can become public, adversely affecting your organization’s image and its commitment to quality, safety, and regulatory adherence.
• Mitigate Risks and Maintain Compliance: Proactive audit preparation is crucial. It helps safeguard against potential risks and the negative impacts on your business, ensuring ongoing compliance with regulatory standards. Remember, the Food, Drug, and Cosmetic Act mandates that “Registered domestic drug establishments shall be inspected by the FDA at least once every two years,” with the possibility of more frequent inspections depending on various factors.
• The Impact of Interactions: The dynamics of how you and your colleagues engage with FDA inspectors can significantly influence the outcomes of these inspections. Mastering effective interaction techniques is vital for steering the results toward positive conclusions.

Bootcamp Benefits:

• Learn from the Experts: Absorb insights, best practices, and actionable strategies from industry veterans who have navigated FDA audits with success.
• Stay Ahead of the Curve: Keep abreast of regulatory updates and refine your compliance strategies to mitigate the risk of non-compliance.
• Network and Collaborate: Engage with professionals across industries, share insights, and enhance your compliance efforts through collaboration.

Maximize your preparedness and position your organization for success in the face of FDA inspections. Join our bootcamp now and transform regulatory challenges into opportunities for excellence.

Enroll Today!

Day 1 & Day 2 Schedule:

9:00 AM – 9:15 AM: Introduction (15 minutes)
9:15 AM – 10:30 AM: First Working Block (1 hour and 15 minutes)
10:30 AM – 10:40 AM: First Short Break (10 minutes)
10:40 AM – 11:55 AM: Second Working Block (1 hour and 15 minutes)
11:55 AM – 12:25 PM: Lunch Break (30 minutes)
12:25 PM – 1:40 PM: Third Working Block (1 hour and 15 minutes)
1:40 PM – 1:55 PM: Closing and Q&A (15 minutes)

DAY 1: Setting the Stage – 4-Hrs + Breaks

FDA Inspection Framework and Risk-Based Prioritization

• Overview of FDA Inspection Operations
• Integration of Risk-Based Approaches and ICH Q9/Q10 for prioritizing GMP Inspection sites
• Discussion on how inspections are planned and prioritized

Types of Inspections and Inspection Targets

• Overview of Pre-Approval, Post-Approval, Product Surveillance, and For Cause Inspections
• Insights into what gets inspected: GCP, GLP, and cGMP
• Who gets inspected and why

Systems-Based Approach to Compliance and Keeping Up with Inspectional Trends

• Exploring the Systems-Based approach
• Latest Inspectional Trends and Enforcement actions
• Case studies and examples of recent findings

DAY 2: Preparation, Inspection Conduct and Do’s and Don’ts – 4-Hrs. + Breaks

Effective Preparation for FDA Inspections

• The role of the FDA Investigator
• Implementing the 3I approach: Implement-Inspect-Incorporate
• Utilizing gap analysis and root cause determination for GCP, GLP, and cGMP

Understanding FDA Inspection Protocols and Conduct

• General FDA Inspection Protocol updates
• Routine inspection coverage and conduct tips
• Importance of truthfulness, knowledgeability, and confidence during inspections

Mastering Inspection Do’s and Don’ts

• Effective communication skills and the role of documentation
• Handling adverse findings and responding to FDA tricks
• Review of critical do’s and don’ts with recent examples

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

Day 1 & Day 2 Schedule:

9:00 AM – 9:15 AM: Introduction (15 minutes)
9:15 AM – 10:30 AM: First Working Block (1 hour and 15 minutes)
10:30 AM – 10:40 AM: First Short Break (10 minutes)
10:40 AM – 11:55 AM: Second Working Block (1 hour and 15 minutes)
11:55 AM – 12:25 PM: Lunch Break (30 minutes)
12:25 PM – 1:40 PM: Third Working Block (1 hour and 15 minutes)
1:40 PM – 1:55 PM: Closing and Q&A (15 minutes)

DAY 1: Setting the Stage – 4-Hrs + Breaks

FDA Inspection Framework and Risk-Based Prioritization

• Overview of FDA Inspection Operations
• Integration of Risk-Based Approaches and ICH Q9/Q10 for prioritizing GMP Inspection sites
• Discussion on how inspections are planned and prioritized

Types of Inspections and Inspection Targets

• Overview of Pre-Approval, Post-Approval, Product Surveillance, and For Cause Inspections
• Insights into what gets inspected: GCP, GLP, and cGMP
• Who gets inspected and why

Systems-Based Approach to Compliance and Keeping Up with Inspectional Trends

• Exploring the Systems-Based approach
• Latest Inspectional Trends and Enforcement actions
• Case studies and examples of recent findings

DAY 2: Preparation, Inspection Conduct and Do’s and Don’ts – 4-Hrs. + Breaks

Effective Preparation for FDA Inspections

• The role of the FDA Investigator
• Implementing the 3I approach: Implement-Inspect-Incorporate
• Utilizing gap analysis and root cause determination for GCP, GLP, and cGMP

Understanding FDA Inspection Protocols and Conduct

• General FDA Inspection Protocol updates
• Routine inspection coverage and conduct tips
• Importance of truthfulness, knowledgeability, and confidence during inspections

Mastering Inspection Do’s and Don’ts

• Effective communication skills and the role of documentation
• Handling adverse findings and responding to FDA tricks
• Review of critical do’s and don’ts with recent examples

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

Everybody benefits from watching this. Even better when done as a group!

NOTE: This webinar applies to all worker levels – Associates, Managers, Directors, Vice- Presidents.

Functions:

• Research & Development
• Technical Services
• Manufacturing
• Compliance and Regulatory
• Quality Assurance and Quality Control
• Logistics/Supply chain
• Service and Maintenance
• Marketing

Everybody benefits from watching this. Even better when done as a group!

NOTE: This webinar applies to all worker levels – Associates, Managers, Directors, Vice- Presidents.

Functions:

• Research & Development
• Technical Services
• Manufacturing
• Compliance and Regulatory
• Quality Assurance and Quality Control
• Logistics/Supply chain
• Service and Maintenance
• Marketing