2018 Update: How to Write Effective SOPs for FDA Inspection and Regulatory Compliance

Event Information
Product Format
Prerecorded Event
90 minutes
Product Description

Train Personnel on SOPs That Are Consistent & Straightforward

Virtually every Food and Drug Administration (FDA) inspection includes a review of standard operating procedures (SOPs). And adverse agency findings are often the result of SOP administration issues. SOPs are required by law for some companies, but FDA offers no guidance for how to write, organize, and maintain SOPs. That means compliance can be difficult—if not downright impossible.

Join regulatory compliance expert Angela Bazigos as she provides the missing guidance on how to draft effective SOPs and then train personnel to ensure compliance. Bazigos will explain how to establish a set of standards that are concise, reproducible, and—importantly—easy to follow.

After attending this audio event, you will know how to create a strategic view of SOPs in your company and how SOPs can help streamline operations and ensure regulatory compliance. You will also understand how to move from regulations to SOPs. And you’ll be armed with best practices to create, implement, and maintain SOPs using a risk-based approach. Never be caught off guard by the FDA again—learn to properly prep your SOPs now.

Session Highlights

Here is a taste of what you will uncover:

  • SOPs and their relation to regulations
  • SOPs as a part of a company’s regulatory infrastructure
  • Standard operating procedures for SOPs—and how to make them concise, consistent, and straightforward
  • A risk-based approach to SOP best practices for creation and maintenance
  • SOP training
  • Tools for SOP tracking and clues to when validation is required
  • What the FDA looks for in SOPs during an inspection

Who Should Attend

  • CEOs
  • Regulatory vice-presidents
  • Quality vice-presidents
  • IT vice-presidents
  • Regulatory affairs professionals
  • Quality managers
  • Quality engineers
  • Small business owners
  • GxP
  • Consultants


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About Our Speaker

Angela Bazigos - Pharma Conferences

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...   More Info
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