2018 Update: How to Write an Effective SOPs for FDA inspection & Regulatory Compliance

Product Id : FDA89
Instructor : Angela Bazigos
Mar 13, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues.

Standard operating procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues. Yet, there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. Worse, this often leads to many regulatory errors that first come to light during an FDA audit.

Join this session, where expert speaker Angela Bazigos will show you how to write, organize, and maintain SOPs and train personnel to ensure compliance in a way that is concise, reproducible and easy to follow. The session will begin with a strategic view of SOPs and how SOPs can help streamline operations in addition to ensuring regulatory compliance in an organization. Angela will provide an explanation of how to create SOPs based on regulatory requirements.  She will also discuss the best practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection.

Session Highlights:

  • SOPs and their relation to the regulations
  • SOPs as a part of the company's regulatory infrastructure
  • SOP on SOPs and how to ensure conciseness, consistency and ease of use
  • Risk-based approach on SOP best practices for creation and maintenance
  • Training on SOPs
  • Tools for SOP tracking and when validation is required
  • What the FDA looks for in SOPs during an inspection

Who Should Attend:

  • CEOs
  • Regulatory VPs
  • Quality VPs
  • IT VPs
  • Regulatory affairs professionals
  • Quality managers
  • Quality engineers
  • Small business owners
  • GxP
  • Consultants
Speaker Profile:

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer : http://morflearning.com/angelabazigos/, Director of QA and MIS Director.  Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA & DIA:

http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom : http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/

Includes training for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents,Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview  

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