Practical Two Day FDA Inspection Online Seminar – Research is pleased to announce the addition of “FDA Inspection” training to its offerings. This two-day seminar is meticulously crafted to equip professionals in the pharmaceutical, biopharmaceutical, biologics, and medical device industries with the essential knowledge and tools to adeptly navigate and manage FDA inspections. Non-compliance with FDA regulations can lead to significant financial repercussions and damage to a company’s reputation, making comprehensive preparation and effective management of inspections imperative.

In this seminar, attendees will learn practical strategies for establishing and maintaining GxP compliance, mitigating risks, and ensuring smooth responses to crises. The program emphasizes a risk-based approach to quality and regulatory compliance across all facets of operations, including GCP, GLP, and GMP. Key topics covered include risk management, document control, compliance training, auditing, and monitoring activities.

Participants will gain insights into the fundamentals of preparing for and surviving FDA inspections, regardless of their industry classification. The seminar will cover essential do’s and don’ts, communication strategies, document review techniques, and appropriate responses to inspection findings such as Form 483s and Warning Letters.

Throughout the course, attendees will receive guidance on preparing for various types of inspections, including those conducted by international agencies and non-FDA entities. Practical tips will be provided for handling both scheduled and unscheduled inspections, as well as post-inspection follow-up procedures.

Why Attend:

  • Develop and implement proven GxP compliance strategies
  • Enhance operational readiness and state of readiness tactics
  • Navigate inspections and post-inspection correspondence effectively
  • Strengthen credibility and trust with regulatory agencies
  • Gain insights into important training areas and topical compliance issues
  • Improve communication with the FDA and other regulators
  • Understand the FDA inspection process and authority, including 483s, Warning Letters, and recalls
  • Learn about mock audits and external certifying audits
  • Explore required documentation formats and response strategies
  • Engage in lively discussions and a mock inspection exercise
  • Earn 12.0 RAC credits pre-approved by RAPS

Who Should Attend:

This seminar is essential for professionals at all levels of management and across key functional areas, including:

  • Executive Management
  • Regulatory Affairs Management and Specialists
  • Auditors
  • QC/QC Management
  • Compliance Officers and Specialists
  • Clinical Affairs Professionals
  • Quality Assurance Management
  • Marketing & Sales Representatives
  • Laboratory Operations Personnel
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Engineering/Technical Services
  • Operations/Manufacturing Personnel
  • Consultants
  • Anyone who interacts with regulatory inspectors

Don’t miss this opportunity to gain valuable insights and tools for effectively managing FDA inspections and maintaining regulatory compliance. Register now to secure your place in this comprehensive online seminar.

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