When: |
06 Dec through 06 Dec 2018 | |
CFP Deadline: |
06 |
|
Where: |
Online Event | United States | |
Website URL: |
https://www.compliancetrainingpanel.com/Webinar/Topic?WB=PH00112 | |
Categories: |
Life Sciences - Biotechnology/ Bioinformatics |
Keywords:
Event description:
Description :
The requirement for the Quality Unit review and approval of document changes is clear in 21CFR211. However, contemporary regulatory expectations for the control of change goes well beyond document change review. The expanded expectation for change control and the Quality Unit responsibilities in the change control process was introduced into the FDA regulated industries in 1996 when it became a requirement for medical devices and was part of the proposed amendments to 212CFR211. Since that Change Control has been an element of the Quality System approach found in ICH Q10 and related guidances. It is important that all individuals involved in the pharmaceutical industry understand the expectations for change control in the everyday pharmaceutical firm operations. In this webinar we will discuss the egulatdory expectations for change control and how change control fits into the pharmaceutical quality system.
Objective :
The objective of this webinar is to help individ...
Read more
Posting date:
27 November 2018 | 175 views
Placement:
Not-featured (How do I make my event featured?)
Flag (Report this event)