Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs) - Webinar By GlobalCompliancePanel November 7, 2012

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.

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 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.

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:
CEO
Regulatory VP
Quality VPs
IT VPs
Regulatory Affairs professionals
Quality Managers
Quality Engineers
Small business owners
GxP
Consultants

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years experience in the Lifescience industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and consults to many Pharma / Biotech / Medical Device and CRO’s on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She 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 on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Lifescience industry. 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.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Event Link - http://bit.ly/Vp1oeT