2019-update-how-to-write-effective-sops-for-fda-inspection-regulatory-compliance

2019 Update: How to Write Effective SOPs for FDA Inspection & Regulatory Compliance

Live Webinar

  • 60 minutes
  • 9 Days Left
     Aug 30, 2019
  •   01:00 PM - 02:00 PM ET
    10:00 AM - 11:00 AM PT

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. 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 by expert speaker Angela Bazigos, where she will explain how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

Session Highlights:

  • SOPs and their relation to the regulations

  • SOPs as 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 is validation required

  • What the FDA looks for in SOPs during an inspection

Why You Should Attend:

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Who Should Attend:

  • CEO

  • Regulatory VP

  • Quality VPs

  • IT VPs

  • Regulatory Affairs professionals

  • Quality Managers

  • Quality Engineers

  • Small business owners

  • GxP

  • Consultants


*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.

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