Excel Spreadsheet Compliance with 21 CFR 11 by compliance2go


									 Live Webinar on : Excel Spreadsheet Compliance with 21 CFR 11
 Thursday, August 02, 2012 duration :    10:30 to 12:00 PM EDT

                                               Why should you attend :

                                               Spreadsheet Applications such as MS Excel are
                                               frequently used in 21 CFR 11 compliant
                                               environments, but they were not specifically
                                               designed for regulated environments and their
                                               development is not optimized for 21 CFR 11
                                               compliance. However, the FDA expects that
                                               spreadsheets be compliant and lack of compliance
Get 15 % Discount as a early bird              can result in a warning letter. Consequently,
registrations. Use Promo Key :                 validation of Excel Spreadsheet Applications is
 CGO15                                         required as part of a 21 CFR 11 compliant

                                              Areas Covered in the Session:
                                               1. Requirements for Excel Spreadsheets

                                               2. FDA Part 11 Validation Guidance
                                               3. Compliance Problems with Spreadsheets

                                               4. Design Specifications for 21 CFR 11 compliance
Live ( Single registration ) : $189.00
Group ( Max 10 Attendee): $249.00              5. How does the FDA Design and Use spreadsheets
On Demand (Recording available):$289
Get Training CD : $449                         6. Documentation for Part 11
Play back(Unlimited views):-309
                                               7. Future Trends in 21 CFR 11 compliance for Excel
    Who will benefit: (Titles)          .
   Quality Managers
   Quality Engineers
   Small business owners                .About Speaker
   Internal and external auditors
   Management Reps
   FDA inspectors
   Consultants
                                         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.

                                         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 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.
                      Compliance2go | www.Compliance2go.com
                      Phone : 877.782.4696 | Fax : 281-971-0286
                        Email : Support@compliance2go.com

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