webinar
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
individuals working in the pharmaceutical understand the regulatory
requirements for change control and how change control integrates into the
pharmaceutical quality system
Areas Covered in the
Session :
The evolution of change control into regulatory
expectations
Why an organization needs change control
How change control fits into the pharmaceutical
quality system
The change control process
Who Will Benefit:
personnel at all levels of a pharmaceutical firm
Senior management
Middle management
line personnel
Quality Assurance personnel
About Speaker:
John G. (Jerry) Lanese is an independent
consultant with a focus on Quality Systems and the components of an effective
Quality System. He received a BA and MS from Middlebury College and a Ph.D. in
Analytical Chemistry from the University of Michigan and began his career
teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved
from the academic environment to the pharmaceutical industry where he has
managed Analytical Research, Quality Control and Quality Assurance
functions.
Venue: Online
Speaker Name: Jerry
Lanese
Priice : $ 239
Thursday Dec 06,
2018.EST 13:00
Duration : 90 Minutes
Website : www.compliancetrainingpanel.com
URL: www.compliancetrainingpanel.com/Webinar/Topic?WB=PH00112