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Historical Perspective of the Part 11 Regulation

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Category Electronic Signatures, electronic signature online, free electronic signature software, types of electronic signatures, online signature, Compliance standards

Deadline: August 04, 2018 | Date: August 06, 2018

Venue/Country: Online, U.S.A

Updated: 2018-06-07 14:29:37 (GMT+9)

Call For Papers - CFP


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


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


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.