How to Write FDA-Compliant SOPs | Oct. 9, 2013, 1 PM EDT | Bazigos
June 29th, 2013 // 8:37 pm @ jmpickett
Standard Operating Procedures (SOPs) are required according to FDA cGMP regulations for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet, surprisingly, 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 and FDA audit.
SOP mistakes are one of the most frequent reasons that companies get 483s during cGMP audits by FDA. Common 483 violations include:
- Failing to follow SOPs
- Using the SOPs for another organization
- Lack of detail in SOPs
- Failure to approve SOPs
This webinar will show you 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.
Areas Covered in the Session:
- 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
Who will Benefit
- Anyone that creates / maintains SOPs
- VP
- Director, Manager of any dept that writes SOPs or performs training
- QA / QC
- Regulatory Affairs Titles
Webinar Includes
- Q and A with the speaker
- PDF print only copy of PowerPoint slides
- 90 Minutes Live Presentation
About Speaker
Angela Bazigos has been accepted into the prestigious ranks of Stanford Who’s Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world.
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Complianceâ€. She has 30 years experience in the Life Sciences industry spanning project management, Quality Assurance and Regulatory Affairs. She has applied for patents aimed at speeding up Software Compliance and FDA Audits.
Angela is a member SQA (Society of Quality Assurance) as well as of the SQA CVIC (Computer Validation Initiative Committee), DIA and RAPS. She provides consulting services to Pharma, Biotech, Medical Device and CRO industries on compliance matters, including strategy, submissions, quality assurance, computer systems validation, and remediation’s following action by the FDA. She also teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management.
More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research, Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is also on the board for UC Berkeley’s Haas Business School for Executive Education in Life Sciences.
