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Site language : English - Français
Ref : 28510
Event :ICH Q 10 Change Management System

Date :Thursday December 06th, 2018

Location :9106 Seven Locks Road, Bethesda, Maryland 20817
Bethesda, United States

Type :Conference & Seminar - International audience

Accreditation :500 crédits - 300


 

Further information

 

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


Location

Map and directions
Conference address :
9106 Seven Locks Road, Bethesda, Maryland 20817
Bethesda
United States
tel : 1-844-216-5230.
Map and directions

Further information

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Compliance Training Panel
Description : Process capability and process performance indices are long-established metrics of a process ability to meet customer specifications. A Six Sigma process, in fact, has six process' standard deviations between the process nominal and the specification limits. If the process is centered on the nominal it will have two [...]

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Details

ICH Q 10 Change Management System Medicine
--
Professionals, Personnel at all levels of a pharmaceutical firm Senior management Middle management line personnel Quality Assurance personnel
500 1 10
English

Other

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