Live Webinar on : Training on Standard Operating Procedures Thursday, June 07, 2012

duration : 10:30 to 12:00 PM EST

Description

Get 15 % Discount as a early bird registrations. Use Promo Key : CGO15

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.

Who will benefit

Areas Covered in the Session:

Anyone that creates / maintains SOPs VP Director, Manager of any dept that writes SOPs or performs training QA / QC
Regulatory Affairs Titles

- 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

Pricing

- What the FDA looks for in SOPs during an inspection

Live ( Single registration ) : $189.00

Group ( Max 10 Attendee): $249.00 On Demand (Recording available):$289

Get Training CD : $499

Why should you attend :

More Trainings

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.

About Speaker
Angela Bazigos has been accepted into the prestigious ranks of Stanford Whos 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 Compliance. 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 remediations 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 Berkeleys Haas Business School for Executive Education in Life Sciences. . https://compliance2go.com/index.php?option=com_training&speakerkey=13&productKey=94
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