Webinar Information


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


Compliance for Electronic Records and Signatures (21 CFR Part 11), Fremont, California, United States
Webinar Title
Compliance for Electronic Records and Signatures (21 CFR Part 11)
Event Type
Webinar
Webinar Date
10-09-2018
Last Date for Applying
08-09-2018
Location
Fremont, California, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
Netzealous LLC DBA - Compliance4All
Organizing/Related Departments
Compliance Trainings & Seminars for all Industries
Organization Type
Organization/Company
Webinar Category
Both (Technical & Non Technical)
Webinar Level
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Accounting/Financial/Banking/Insurance

Manufacturing

Medical/Healthcare/Hospital

Location
Fremont, California, United States

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

Registration Fees
Available
Registration Fees Details
One Dial-in One Attendee Price: $150.00
Registration Ways
Phone
Website
Address/Venue
Online  Pin/Zip Code : 94539
Official Email ID
support@compliance4All.com
Contact
Event Manager

Online

support@compliance4All.com

     +1-800-447-9407
   Fax No: 302-288-6884