Live webinar By Compliance2go

							 Live Webinar on : Effective Root Cause Analysis and CAPA Program
 Thursday, June 07, 2012 duration : 10:30 to 12:00 PM EST



                                       Description


                                       This webinar will show you how to write,
                                       organize, and maintain SOPs and train personnel
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                                       in a way that will ensure compliance in a way that
registrations. Use Promo Key :
                                       is concise, reproducible and easy to follow.
 CGO15



                                       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
                                         Why should you attend :

Who will benefit                         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
Anyone that creates / maintains          there is no guidance on how to write, organize and
SOPs                                     maintain SOPs. Consequently, SOPs are frequently
                                         written in a way that makes compliance difficult or
VP                                       downright impossible. Worse, this often leads to many
                                         regulatory errors that first come to light during and FDA
Director, Manager of any dept that       audit.
writes SOPs or performs training

QA / QC
                                         About Speaker
Regulatory Affairs Titles
                                         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
Pricing
                                         the business world.

                                          Angela Bazigos is the CEO of Touchstone
Live ( Single registration ) : $189.00   Technologies Silicon Valley, Inc. “Your Passport to
Group ( Max 10 Attendee): $249.00        Compliance”. She has 30 years experience in the
On Demand (Recording available):$289     Life Sciences industry spanning project
Get Training CD : $499                   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
More Trainings                           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 remediation’s 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 Berkeley’s 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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