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A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs) - Webinar

  • ID: 3388741
  • Webinar
  • 90 Minutes
  • Redstone Learning
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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.

Course Objective:

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 a FDA audit. 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.

Course Outline:

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.

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

Target Audience:

- CEO
- Regulatory VP
- Quality VPs
- IT VPs
- Regulatory Affairs professionals
- Quality Managers
- Quality Engineers
- Small business owners
- GxP
- Consultants
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Angela Bazigos, is the Chief Compliance Officer of Morf Media. She has 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance. 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 LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, 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 Virtual Validation of Software. 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 Lifesciences industry.
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