Validation and Part 11 Compliance


Joy L. McElroy is Keynote speaker at ComplianceKey. Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. She then moved into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. From there she moved into auditing clinical and GMP laboratories, and manufacturing facilities, then into validation engineering. Now with 14 years experience as a consultant, and over 20 years total experience in the pharmaceutical ........

Overview

This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, regulated companies must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters.

Why should you attend this webinar?

Participants will understand what is expected in Part 11 and Annex 11 inspections, they will learn how to avoid 483s and Warning Letters. Participants will understand how to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds, and understand what are the requirements for local, SaaS, and cloud hosting. By attending this webinar, attendees will learn how to select resources and manage validation projects, they will understand how to minimize the validation documentation to reduce costs without increasing regulatory or business risk. Finally, participants will know how to write test cases that trace to elements of risk management and how to protect intellectual property and keep electronic records.

Areas Covered in the Session:

Who can Benefit:



Webinar Id: LSHCJME003

Training Options:

Duration: 90 mins

 Stop, pause, and rewind: learn at your own place.

Ratings:
No reviews yet!!
 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

Refund Policy
Past Webinar of Joy McElroy
FDA Inspections : What Regulat....
Presenter: Joy McElroy
View it anytime
Price: $167
Technical Writing for the Phar....
Presenter: Joy McElroy
View it anytime
Price: $167

More Webinar

Upcoming Webinar: Life Sciences and Healthcare
How to Increase your Revenue b....
Presenter: Gregory J Simms
When: 06/03/2019 | 12:30 PM PT |03:30 PM ET
Price: $179
Employment-at-Will! Does It Pr....
Presenter: Janette Levey Frisch
When: 06/06/2019 | 12:30 PM PT |01:00 PM ET
Price: $179

More Webinar

Past Webinar: Life Sciences and Healthcare
Contemporary Acute Care Case M....
Presenter: Toni G. Cesta
View it anytime
Price: $167
The Complexity and Interplay A....
Presenter: Dr. Susan Strauss RN Ed.D
View it anytime
Price: $167

More Webinar

Insert title here
Pay Pal Logo   PayPal Verified Logo   GoDaddy Certified
Copyright © 2018 Compliance Key . All Rights Reserved. Back to Top