Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
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. 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 Speaker Profile Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://www.compliance4all.com/control/w_product/~product_id=500432LIVE/ firstname.lastname@example.org www.compliance4all.com
Overview: 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.
Anyone that creates / maintains SOPs VP, Director, Manager of any dept that writes SOPs or performs training QA / QC Regulatory Affairs
Tuesday, August 4, 2015 | 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Minutes