Effective and Compliant Change Control Management - Before, During and After Validation - Webinar By GlobalCompliancePanel

Event Details

Time: May 2, 2013 from 10am to 11:30am
Location: Online Training
Street: 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
City/Town: Fremont
Website or Map: http://bit.ly/17cT7hi
Phone: 8004479407
Event Type: webinar, healthcare, medical, device, pharmaceutical, clinical
Organized By: John Robinson
Latest Activity: Apr 29, 2013

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Event Description

Overview: There is a need to implement an adequate formal level of change control during engineering projects (referred to as an Engineering Change Control) after the approval of the equipment/systems specifications in addition to the more formal change control after the qualification of these systems. The Engineering change control process will apply through design, construction and qualification up to the point that the system is considered installed/operational. The new Quality Systems guideline from the FDA states that the Quality function must be involved in the review of the design and subsequent changes to the design of facilities, equipment and systems that may impact the product quality.

Why should you attend: Most pharmaceutical companies focuses on change control management after commercialization but changes must be managed earlier during the design of facilities, equipment and systems in addition to changes implemented during the development of the manufacturing processes. The question is: What is the level of control required at the design/development stages? Who needs to be involved? What are the steps required for the processing of such changes and the documentation that is required to provide evidence of such controls?

Course Modules & Content Details:

Specifications Change Control - Handling of changes to URS, FRS, Design Specifications and When do we implement some level of Change control
Design Change Control - Relationship between Design Qualification/Review and Change Control and Adequate/Practical Documentation Requirements for changes during design - handling of drawings
Change Control during Construction, Start-Up and Commissioning
Formal Change Control Management after Equipment/Systems Qualification
- Definitions - Like for Like, Emergency/Unplanned vs. Normal/Planned Changes
- Applications for Documentation Changes
- Applications for Process Changes
- Applications for Changes in equipment/systems

Who Will Benefit:

Manufacturing
R&D
Quality
Validation
Engineering
Top Management

Miguel Montalvo, B.S. Chem. Eng., MBA, President, Expert Validation Consulting, has over twenty-eight years of professional/management experience in positions of increasing responsibility in the areas of Quality, Validations and Technical Services within the traditional pharmaceutical, OTC Drugs, cosmetics, dietary supplements, biotechnology.

Price: $245.00

GlobalCompliancePanel

NetZealous LLC,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

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