Essential Preparation and Management Tools for Successful FDA Inspections: What Regulators Expect and How to Prepare (2 Day Online Training Course) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Successful FDA Inspections: Essential Preparation and Management Tools - What Regulators Expect and How to Prepare" training has been added to ResearchAndMarkets.com's offering.

The "Successful FDA Inspections" training course prepares professionals for the rigors of FDA regulatory inspections. The training is tailored for individuals involved in various aspects of FDA-regulated operations, including quality control, plant management, technical services, and regulatory affairs.

Training Benefits and Learning Outcomes

• Preparation for Inspections: Trainees learn about pre-inspection planning and the groundwork required for a smooth audit process.
• Interaction with Inspectors: The course teaches effective communication with FDA inspectors and the proper protocol for managing inspection rooms, including 'war rooms' for support.
• Documentation and Compliance: It emphasizes the importance of having the correct documentation ready and understanding the company's compliance with CFR requirements.
• Inspection Management: Participants are trained to manage the actual inspection process, including accommodating FDA agents and guiding their activities within the facility.
• Staff Training: A crucial aspect of preparation involves training staff on their roles during the inspection and ensuring all job function training is documented.

Key Topics and Structure

• Day 1 Agenda: Focuses on background management, audit preparation, company readiness, and conducting mock inspections.
• Day 2 Agenda: Addresses how to respond to FDA Form 483 (a form used by the FDA to document concerns discovered during inspections), Corrective and Preventive Actions (CAPA) related to FDA observations, and reviews real-life inspection scenarios and case studies.

Expert Speaker Danielle DeLucy, the principal trainer, brings extensive experience in quality assurance and systems management within the pharmaceutical industry. Her background includes guiding companies through regulatory health inspections and addressing quality system improvements post-warning letters and consent decrees.

Training Goals and Regulatory Context The training aims to transform an FDA inspection from a potentially adverse experience into a constructive one by demonstrating a firm's high level of compliance and commitment to product safety and quality.

Who Should Attend The course is designed for a broad spectrum of professionals from the pharmaceutical and biotech industries, ensuring that various departmental roles are equipped to handle FDA inspections effectively.

Training Agenda:

Day 1

• Module 1: Background/SME management
• Module 2:
  • Preparing for FDA audits
  • Do's and Don'ts
• Module 3:
  • Company preparation
  • FDA Game Show
• Module 4: How to do mock inspections

Day 2

• Module 1:
  • 483 background
  • How to respond
• Module 2: CAPA and the 483
• Module 3: Real life inspection scenarios
• Module 4: Case Studies

For more information about this training visit https://www.researchandmarkets.com/r/lha7g8

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