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

Sign for Notice Everyday

Home Post Event 2025Event 2026Event By Topic By Country Contact

Our Sponsors

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

Website http://bit.ly/GRZBKB | Edit Freely

Category Seminar, Health, Medical, Pharma, Clinical

Deadline: November 07, 2013 | Date: November 07, 2013

Venue/Country: USA, U.S.A

Updated: 2013-10-17 15:42:18 (GMT+9)

Call For Papers - CFP

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 and medical device industries including extensive expertise on development and implementation of quality functional procedures (QA/QC), Quality Systems, GMP/QSR compliance audits (internal, supplier, external audits), remediation projects with companies on consent decrees, handling of non-conformances (OOS, investigations and deviations), Process/Cleaning/Computer Systems/Equipment/Facility validations, Change Control, CAPA, international GMP compliance, Calibrations, Risk Management, operational compliance assessments/Gap Analysis and start-up of manufacturing facilities.

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/16coXyk

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.