Webinar Information


Webinar on FDA 21 CFR Part 11 Compliance: Streamline Your Transition to Electronic Records


Webinar on FDA 21 CFR Part 11 Compliance: Streamline Your Transition to Electronic Records, Aurora, Colorado, United States
Webinar Title
Webinar on FDA 21 CFR Part 11 Compliance: Streamline Your Transition to Electronic Records
Event Type
Webinar
Webinar Date
16-04-2019
Last Date for Applying
16-04-2019
Location
Aurora, Colorado, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Life Science
Organization Type
Organization/Company
Webinar Category
Both (Technical & Non Technical)
Webinar Level
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Biotechnology

Medical/Healthcare/Hospital

Location
Aurora, Colorado, United States

OVERVIEW

Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483s at their next inspection. Our upcoming webinar discusses what FDA 21 CFR Part 11 compliance is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

The webinar covers the following key areas:

  • Origin of the FDA regulation and changes in interpretation
  • Electronic records
  • CFR electronic signature

 

LEARNING OBJECTIVES

This webinar will explain what FDA 21 CFR Part 11 compliance 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 regulation will be explained.

 

WHO WILL BENEFIT

Engineering personnel

QA

IT

Management

Compliance Officers

Regulatory Affairs

Safety Manager

Document Control

Medical Affairs

 

SPEAKER

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 9 years.

 

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Use Promo Code MKT10N and get flat 10% discount on all purchases

To Register (or) for more details please click on this below link:

https://tinyurl.com/y48mfja3

Email: [email protected]

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Others Details

Learn about 21 CFR Part 11 conformance for medical devices, including what is selective enforcement of FDA regulation. Also learn about electronic record and signature validation.

Registration Fees
Available
Registration Fees Details
Live Session for one participant $199 Corporate Live Session Group – Max 10 Participants from one location. $549 Recorded Session Get unlimited access to the link for six months $219 Training DVD or USB Flash Drive MP3 files, PDF presentation and reference manual will be delivered on a CD $399 Super Combo Offer 1 Live and Recorded webinar $329 Super Combo Offer 2 Live and Training CD $499
Registration Ways
Email
Phone
Website
Other
Address/Venue
Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016  Pin/Zip Code : 80016-6104
Landmark
CO
Official Email ID
Contact
Training Doyens

Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016

[email protected]

   +1-720-996-1616