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Ref : 27642
Event :Compliance for Electronic Records and Signatures (21 CFR Part 11)

Date :Monday September 10th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

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
http://www.compliance4all.com/control/w_product/~product_id=501949LIVE?channel=doctorama_Sep_2018_SEO

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Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Compliance for Electronic Records and Signatures (21 CFR Part 11) Pharmacy - Medicine - Infectious Diseases - Hygiene
health education, healthcare professionals training
IT QA QC Laboratory Staff Managers GMP, GCP, GLP Professionals
50 1 --
English

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