Historical Perspective of the Part 11 Regulation

Fremont (United States), 6 August 2018


Key deadlines
Conference starts:
2018-08-06
Website

Visit the conference website

Conference Description

Overview:
This presentation will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements,electronic records requirements, and electronic signatures requirements.

Why should you Attend:
Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.Understanding the requirements of Part 11 is critical to compliance with the regulation.Knowledge of regulatory requirements is an exercise in efficiency both efficiency in project management, and avoidance of non-compliance penalties.

Areas Covered in the Session:
History and Overview
Subpart A: General Provisions
Subpart B: Electronic Records
Subpart C: Electronic Signatures
Scope & Application Guidance
Questions and Answers

Who Will Benefit:
Project/Strategic Management
IT Staff
Operations Staff
Quality Assurance Staff

Speaker Profile:
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds.

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

Conference creator: compliance4all

Actions menu

Conference Location

image placeholder

18004479407 161 Mission Falls Lane, Suite 216,,
Fremont 94539 (United States)

Tags for this conference

Comments

No comments yet!

You must register or sign in to post a comment.