Document Control & Records Management Class September 20, 2008
San Jose, California 95121
Title: Document Control & Records Management
Class Date: September 20, 2008
Time: 8am to 12pm, 1pm to 5pm (8 hours total)
Cost:
Non ASQ Member, employed: $220
Member, employed: $175
Non Member, Unemployed: $80
Member, Unemployed: $70
Instructor: Deborah Blackmon
From: Jim Bischof (901 to 1400) AH
Class Coordinator
Phone: (H) 408-972-8852
Cell: 408-806-5139
e-mail:
[email protected] e-mail address is being protected from spambots. You need JavaScript enabled to view it
Today's Date: August 11, 2008
Subj: Upcoming Biomedical Class (Document Control & Records Management)
Dear Members of the Quality Advisory Board and other interested parties:
Below is a description of the next upcoming Biomedical Class provided to the Silicon Valley Section of ASQ.
Title: Document Control & Records Management
Class Date: Seeptember 20, 2008
Time: 8am to 12pm, 1pm to 5pm (8 hours total)
Cost:
Non ASQ Member, employed: $220
Member, employed: $175
Non Member, Unemployed: $80
Member, Unemployed: $70
Instructor: Deborah Blackmon(
[email protected] e-mail address is being protected from spambots. You need JavaScript enabled to view it )
Location: TBD (Registered students will be given directions to the classroom, usually two to three days before the class. Most likely, the class will be in San Jose or Santa Clara.)
#625 Document Control and Records Management in Regulated Environments
This overview course focuses on the regulatory environment in the United States for management of standard operating documents and the subsequent management of the resulting paper and electronic records. It is updated annually and designed to provide you with practical knowledge for managing a document control or records department in a manufacturing company. The course provides a basic understanding of the national and international laws and their impact on the lifecycle of documents from use in the FDA manufacturing environment to records retention and disposition.
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There will be specific discussions on texts from these applicable laws and standards:
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21 CFR 11, Electronic Records and Electronic Signatures,
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21 CFR 210 cGMP Manufacturing
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21 CFR 211 cGMP Finished Pharmaceuticals
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21 CFR 820 Quality System Regulation (Devices)
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ICH Guidelines Q7A cGMP for Active Pharmaceutical Ingredients
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ISO 9000 family of standards
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ISO 13485 Quality Management System (Medical Devices)
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ISO 17799 Information Security
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Overview of various quality tools such as 5S as it applies to document control and records management.
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Overview of archival practices and how that differs from records retention.
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Overview of current security and privacy laws and the effect on the controls inherent to document control and records retention.
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Discussion of how the FDA and EMEA see document control and records management from an auditing standpoint and some audit tips.
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CD with regulatory texts.
Instructor: Deborah Blackmon, CQM/OE, CQIA
Deborah Blackmon is currently Manager of the Corporate Facilities Services Document Control Group at Genentech Corp. in South San Francisco CA. She has been involved in their reengineering effort to create a corporate documentation program for calibration and preventative maintenance program documents for more than three years, primarily focusing on the creation of a global site document series and training programs applicable to both cGMP and cGLP maintenance processes used in product manufacturing and the new Clinical Center of Excellence at South San Francisco CA.
Previous roles at Philips Medical Systems included leadership in projects to create an enterprise-wide Quality Manual and Quality Documentation System and to introduce electronic document management processes into the medical imaging device manufacturing plant at the Milpitas CA site. Deborah has a B.A. in Journalism from Texas A&M University and is Vice Chair of the Silicon Valley ASQ Section and holds the CQIA and CQM/OE certifications.
Please note new registration instructions: To register for this class, complete the registration form below, including credit card information, and FAX it to Jim Bischof.
If paying by check, make check out to ASQ, and mail immediately to Jim Bischof, 5666 Keymar Drive, San Jose, CA, along with the completed registration form.
If you have questions about registration, contact Jim Bischof 408-972-8852 or
[email protected] e-mail address is being protected from spambots. You need JavaScript enabled to view it
Biomedical Class
Course Registration Form
(Please use one registration form for each class you register for. FAX this completed form to 1-408-362-9083. The class coordinator will provide you confirmation that you are registered.)
Class Title: _____________________________________________________________
Class #: _____________ Today’s Date ___________________
Class Date: ____________________
Price: ____________________________
Member Number: ___________________
NAME ___________________________________________________
(Print your name like you want it on your certificate)
HOME ADDRESS_________________________________________________
CITY _________________________ ZIP _________________
COMPANY _______________________________________________________
COMPANY ADDRESS_________________________________________________
PHONE (H) ____________________ (B) _____________________________
E-MAIL _________________________Cell: __________________
How did you find out about this class? ___Friend ___Boss ___The Gate ___ASQ Silicon Valley Section Web Page
___e-mail from Jim Bischof Other (Specify) _________________________________________________________
Unemployed ____
Method of Payment (
Circle one)
(1) Check ( ) (Make checks payable to ASQ )
(2) Credit Card: ( ) Card # ____________________________________
Expiration Date (mm/yy) ______________ Name as it appears on your credit
card:________________________________
Circle Credit Card Type: VISA Mastercard American Express (These are the only 3 credit cards accepted
Official Website: http://www.asq-silicon-valley.org/content/view/19/36/
Added by robpower on August 25, 2008