FDA Inspections Seminar for 2024

Attending this seminar will enable you to define and execute proven GxP compliance strategies, ensuring operational readiness and optimal pathways during inspections. You will learn to identify visible signs of GxP compliance and demonstrate risk-based awareness, improving credibility and trust with FDA and other regulators. Gain a deeper understanding of how to interact and communicate effectively with the FDA, learning the ground rules and do's and don'ts of FDA inspections.

This seminar will cover critical training areas in GxP compliance, helping you understand what the FDA can and cannot request during an inspection. Learn the importance of pre-inspection planning and how to navigate the inspection process from preparation to close-out. Understand the FDA's authority and processes, including handling 483s, Warning Letters, and recalls. Explore the benefits of mock audits and the required documentation, formats, and archiving methods.

By attending, you will learn how to respond to inspection and audit results, discussing pain points and challenges in a group setting to find workable solutions for FDA inspections. Prepare for interactive discussions and a mock inspection exercise to enhance your skills in communicating with the FDA and referencing FDA guidance and resources. This seminar is essential for anyone involved in FDA-regulated industries, providing the knowledge and tools to ensure your company remains compliant and prepared for any inspection.

• Executive Management
• Regulatory Affairs Departments
• Quality Assurance Departments 
• Quality Control Departments 
• Compliance Departments 
• Clinical Affairs Professionals
• Laboratory Professionals
• Engineering Departments
• Auditors
• Technical Services
• Operations Departments
• Manufacturing Departments
• Production Departments
• Project Managers
• Consultants
• Everyone who come in contact with regulatory inspectors

DAY 1 (9 AM to 2 PM)

Lecture 1: Introduction and FDA Inspection Authority

• Introductions and Background
• FDA’s Inspectional Authority and History
• Why inspections are conducted and by what statutory authority
• The emphasis on systems-based inspections and crucial FDA reference documents (e.g., IOM)
• What is subject to FDA purview and what's off-limits

Lecture 2: Preparing for an FDA Inspection

• FDA Inspection Program Overview
• Key factors for a successful FDA inspection
• Quality System Readiness
• Organization Readiness
• The company's Inspection Plan (SOP) and training personnel

Lecture 3: Managing the Inspection Process

• How a firm should prepare for an FDA inspection
• Ways to train employees in view of the inspection
• How to ensure that required documentation is in place
• How to interact with the investigator - DO's and DON'T's
• Understand and apply the do's and don'ts for successful inspection preparation

Lecture 4: Post-Inspection Activities

• What companies should do when the inspection ends
• How to reply to 483's and warning letters
• Legal implications of non-compliance
• How to respond to findings and facilitate the documentation and remediation process
• Reaching final closure and the importance of the inspection response team

Lecture 5: Roles, Responsibilities, and Exit Interview

• Define clear responsibilities, roles, and goals for personnel involved in FDA inspections and SOP development
• Exit Interview
• FDA interviewing employees and personnel

DAY 2 (9 AM to 2 PM)

Lecture 1: Maintaining Regulatory Compliance

• Maintain or return to regulatory compliance and minimize downtime
• Establish a risk management plan to proactively manage compliance, including a crisis-management plan
• Set post-inspection deadlines and work closely with FDA’s regulatory partners
• Compliance remediation: recognizing problems, creating a correction plan, preventing future issues, and executing the plan as part of your GxP Compliance Strategy

Lecture 2: Effective Communication with the FDA

• Guidance on how to request and conduct PDUFA meetings and expectations for Sponsor-FDA Meetings
• Guidance outlining clear recommendations for sponsors and FDA staff for Pre-Submission meetings, including expected timeframes for scheduling
• Mechanics of requesting any FDA meeting and strategies for successful communication, approach, and tactics

Lecture 3: Handling Enforcement Actions

• Prioritize follow-up on warning letters and other enforcement actions
• Develop and implement a formal warning letter “close-out” process
• Understanding Untitled Letters and Warning Letters

Lecture 4: Application and Final Review

• Recap of Day 1 and Day 2
• Review Regulatory and Compliance Documentation
• Recent Trends and Enforcement Actions for 2024
• Mock Inspections and Mock Audits: the importance of role-playing
• Final Q&A Session

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.