EXCEL SPREADSHEET?, 21 CFR 11,FDA RECOMMENDATIONS, 2013 - Excel Spreadsheet Compliance with 21 CFR 11 By Angela Bazigos

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Category Medical Device ; Biotechnolgy ; Pharma

Deadline: March 19, 2013 | Date: March 20, 2013

Venue/Country: Houstan, U.S.A

Updated: 2013-02-08 21:49:18 (GMT+9)

Call For Papers - CFP

This course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

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 can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

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

5. How does the FDA Design and Use spreadsheets

6. Documentation for Part 11

7. Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Who will Benefit

Quality Managers

Quality Engineers

Small business owners

Internal and external auditors

Management Reps

FDA inspectors

Consultants

About Speaker

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley and has almost 30 years experience in Life Science. She applied for a patent to speed up computer systems validation and FDA software audits in the life sciences industry which was approved in June 2012. She has co-authored “Computerized Systems in Clinical Research” with the FDA, DIA and Academia and teaches classes in Project Management, 21 CFR 11, Computer Systems Validation (CSV), Quality Assurance and IT. She is the Vice President of the Pacific Regional Chapter of Society of Quality Assurance and writes articles for the SQA journal. She is also a member of DIA, RAPS and CVIC. She was recently inducted into Stanford’s Who’s Who for contributions to the Life Sciences industry.

Ms. Bazigos has worked in various capacities at Roche, Price Waterhouse Coopers, Incyte Genomics, Abgenix, Novartis, Chiron, Applied Biosystems, Clinimetrics, and Veracyte, respectively. More recently, Ms. Bazigos was recognized as an industry subject-matter expert by the FDA and DIA. Ms. Bazigos graduated from North Staffordshire University (England, UK) with an MSc in Computing and University of Reading (England, UK) with a BSc in Microbiology & Biochemistry.

Speaker : Angela Bazigos

Product ID : F62189

Schedule Date :

Wednesday, March 20, 2013

duration : 01:00 to 02:30 PM EDT

https://compliance2go.com/index.php?option=com_training&speakerkey=13&productKey=28