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Compliance for Electronic Records and Signatures (21 CFR Part 11)

View: 16

Website http://www.compliance4all.com/control/w_product/~product_id=501949LIVE?channel=ourglocal_Sep_2018_SE | Edit Freely

Category Laboratory Staff, Managers, GMP, GCP, GLP Professionals

Deadline: September 08, 2018 | Date: September 10, 2018

Venue/Country: Online, U.S.A

Updated: 2018-07-04 15:23:21 (GMT+9)

Call For Papers - CFP

Overview:

Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.

Areas Covered in the Session:

Which data and systems are subject to Part 11

What Part 11 means to you, not just what it says in the regulation

Avoid 483 and Warning Letters

Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation

Ensure data integrity, security, and protect intellectual property

Understand the current computer system industry standards for security, data transfer, and audit trails

Electronic signatures, digital pens, and biometric signatures

Who Will Benefit:

IT

QA

QC

Laboratory Staff

Managers

GMP, GCP, GLP Professionals

Speaker Profile:

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.