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Overview
Design Qualification/Review is a new concept being applied to facilities, equipment and systems in the drug manufacturing industry. The FDA is enforcing this through the application of the new guideline on Quality Systems and the ICH Quality guidelines such as the Q7A and the future Q10. It is a concept that makes business common sense - review the design to meet your specifications. ISPE has developed a concept of an "Enhanced Design Review" that is more adequate to the pharmaceutical industry in the application to facilities, equipment and systems.
Who Should Attend
Quality, Manufacturing, Facilities/Process Engineers, Designers/Contractors for Facilites/Process Systems, Top Management
Industry: Pharmaceutical, Biotechnology, Medical Device
Learning Objectives
Attendees will learn how to:
• Define the requirements to complete a Design Review of a major project
• Develop a Design Review policy/procedure and the applicable forms/documentation
• Determine the responsibilities of each functional group and the level of involvement during the design review process
This web seminar will identify the following challenges/issues and discuss solutions being offered
Challenge is to assure a design for a new/modified facility/system/equipment will meet all requirements including GMP, timing, user, functional and others. The solution is to perform and document the design review involving all parties (User, Quality, designer) before the actual construction starts as the cost of making changes later will be much higher and the consequences can have a much bigger impact on the project.
Presenter
Miguel Montalvo
Expert Validation Consulting, Inc.
Miguel Montalvo, B.S. Chem. Eng., MBA, has over twenty-seven 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.
Before starting EVC, Mr. Montalvo held senior level positions of increasing responsibility in the areas of Validation, Technical Services and Quality Operations in companies such as AAC Consulting Group, Inc, Millipore Corporation, Raytheon Engineers and Constructors, Mova Pharmaceutical Corp., Bristol-Myers Squibb and Baxter Healthcare Corporation. His experience includes roles in the manufacturing side but also from the supplier point of view as QA Manager for the Custom Systems Division of Millipore Corp.
He is a well-recognized international speaker on GMP Compliance, Validation and Quality related topics for organizations such as IVT, PDA-TRI, CfPIE and Barnett International and his articles/papers have been published in the American Pharmaceutical Review and the Journal of Validation Technology publications and have been published as an author of specific chapters in several design/quality/validation related internationally-recognized reference books. He is a previous member of the Journal of Validation Technology editorial board and a current member for the last five years of the PDA Annual Program Committee for their Annual meetings.
Registration Fee
Individual: $225
Group:
2 people: $180.00 each
3 people: $150.00 each
4 people: $120.00 each
5-10 people: $100.00 each
11-15 people: $70.00 each
16-20 people: $60.00 each
21+ people: Call for pricing
Register by December 31 and receive 30% discount off above prices.
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