Angela Bazigos 2012 - What the FDA looks for in SOPs during an inspection

Why should you Attend:

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 and 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.

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

https://compliance2go.com/index.php?option=com_tra...