FDA Inspections Seminar for 2024

AGENDA:

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

About The Course:

Non-compliance is a costly risk that healthcare companies cannot afford. To avoid product approval delays, recalls, and adverse impacts on shareholder value, companies must establish robust GxP compliance strategies and risk mitigation approaches. This seminar will cover the essential strategies for ensuring compliance with GCP, GLP, GMP, and other FDA regulations. We'll discuss how to implement a risk-based approach to managing quality and regulatory compliance, emphasizing the importance of effective risk management, document control, compliance training, ongoing auditing, and monitoring activities.

This two-day seminar is designed to equip pharmaceutical, biopharmaceutical, biologics, and medical device professionals with the necessary tools to efficiently manage FDA inspections. Learn the fundamentals of preparing for and surviving FDA inspections, whether you are a Class I, II, III device manufacturer or a pharmaceutical or biologics producer. The course will cover the do's and don'ts of FDA inspections, including interviewing techniques, responding to questions, reviewing documentation, and handling 483's and Warning Letters. We will also explore the procedures for hosting and following up on inspections, ensuring readiness, and managing scheduled or unscheduled inspections.

In addition to FDA inspections, this seminar will provide insights into inspections conducted by international and non-FDA agencies, including self-inspections and mock audits. Participants will learn how to prepare for inspections, handle them effectively, and understand the follow-up process. This comprehensive training will ensure all employees are aware of inspection procedures, minimizing surprises and enhancing compliance.

Why Should You Attend

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

Who Should Attend:

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