Historical Perspective of the Part 11 Regulation

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: [email protected]