21 CFR Part 11 - Compliance for Electronic Records and Signatures

  • 150.00 Dollar US$
  • Published date: June 25, 2019
    • Fremont, California, United States

Overview:
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.

The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained. FDA requirements for 21CFR Part 11 validation will be explained. the requirements are composed of technical and procedural aspects. open, closed and hybrid (paper and electronic) systems will be explained.

Why should you Attend: Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483's at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would "selectively enforce" sections of the regulation.

This webinar will explain what all this means. A 21CFR checklist and a Test protocol form will be given as handouts .

Areas Covered in the Session:

Origin of the regulation and changes in Interpretation
Electronic Records
Electronic Signatures
Data Security
Open, closed and hybrid Systems
Validation Methods
Risk Analysis

Who Will Benefit:
Engineering Personnel
QA
IT
Management

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: compliance4all14@gmail.com

Result 0 votes
Compliance4All
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Impact Damages - Fact or Fiction?

    Impact Damages - Fact or Fiction?

    Quality Control, Safety & Security Fremont (California) May 27, 2019 110.00 Dollar US$

    Overview In this session, industry veteran James G. Zack, Jr., will discuss impact damages and what they may include. You will gain a better understanding of impact damages and the issues surrounding this form of damages. This session will also explo...

  • Demystifying Excel Pivot Tables

    Demystifying Excel Pivot Tables

    Quality Control, Safety & Security Fremont (California) May 27, 2019 110.00 Dollar US$

    Overview We'll begin by helping you ensure that your data is in the right shape to create a pivot table. This is the place most people stop on their journey. Some of the fixes are so simple you'll be amazed. Then, onto actually creating pivot tables,...

  • 3-Hour Virtual Seminar on FDA Imports Require Precision in 2019

    3-Hour Virtual Seminar on FDA Imports Require Precision in 2019

    Quality Control, Safety & Security Fremont (California) May 23, 2019 290.00 Dollar US$

    Overview: After attending this 3-Hour Virtual Seminar, you will have great understanding of how FDA and Customs and Border Protection (CBP) operate a joint program. Why should you Attend: If you understand FDA's and CBP's import program, your busines...