ComplianceOnline

Deviations, Investigations and CAPA - The latest FDA and EMA hot area for citations, warning letters and other actions

Instructor: Peter Calcott
Product ID: 701968
  • Duration: 90 Min

Training CD

$449.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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Read Frequently Asked Questions

This Deviation, Investigation and CAPA training will provide valuable assistance on how to avoid costly regulatory action from agencies when they inspect your facilities in pharmaceutical and biotech industries. It will show you how to assess your systems and bring them into compliance.

Why Should You Attend:

The agencies have focused over the last 2 years on the investigation/CAPA system as a critical Quality System that is required in a compliant operation. While the agencies have stepped up interpretation of the regulations and have more strongly enforced these regulations, industry has not responded well to this change as evidenced by the breadth and number of warning letters issued over the last 2 years in the US. Thus, this process takes a central position in operations since even the best planned and validated process can result in excursions that contribute to an outcome that is unexpected or unplanned and unwelcome.

Identifying these excursions quickly is critical in maintaining or returning your operations to a validated state. These identified events must be investigated and the root cause discovered. But, equally important is identifying what did not cause the problem. While, correcting these errors or excursions, if well executed, may save product that has been put in jeopardy, it is equally important to prevent their reoccurrence from a business and regulatory perspective. These Corrective and Preventive Actions (CAPA) must be tracked to completion and tested to assure that they are effective.

All of these activities must be thoroughly documented for future reference and to assure the regulatory bodies are convinced you are in control of your operations and in compliance.

This training will provide valuable assistance on how to avoid costly regulatory action from agencies when they inspect your facilities in pharmaceutical and biotech industries. It will show you how to assess your systems and bring them into compliance.

Areas Covered in the seminar:

  • The various types of deviations, discrepancies, Out of Specification and Out of Trends, action limits and alerts.
  • The impact of these excursions on your operations and product.
  • To identify the lightning rods that will lead the inspector to scrutinize your reports and investigations.
  • To differentiate planned and unplanned deviations and manage them appropriately to your advantage.
  • The tools of the investigation process and how much investigation is too much.
  • How to establish good documentation practices in investigations and CAPA?
  • To tie investigation results into operations and dispositioning materials.
  • How to write a good CAPA and then track progress and effectiveness.
  • To know when an investigation and CAPA are completed.
  • Where a good CAPA system can be used in other systems.

Who will benefit:

This webinar will provide valuable assistance to all in pharmaceutical and biotech industries who manufacture products for clinical and commercial uses. The employees who will benefit include:
  • QA staff and management
  • Regulatory Affairs staff and management
  • QC staff and management
  • Compliance auditors
  • Manufacturing management
  • Plant engineers and management
  • Project managers working in the CMC arena
  • Senior managers and executives

Instructor Profile:
Peter Calcott, Ph.D. is founder and President of Calcott Consulting which serves the biotech, Pharma and venture capital industry. It provides consulting services in supply chain development and management, quality systems development and implementation, clinical development and monitoring, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.

He has held positions in industry in all these disciplines over a 30 year career. He has presented at national meetings and is active in the biotechnology community via BIO and the bay area BayBio trade associations where he is chairman of the BIO RAC committee and a Board member of BayBio.

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