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The Center for Professional Advancement, Isla Verde, Puerto Rico
May 29-30, 2008
Who Should Attend
This overview course is intended for individuals in all industries, but specifically individuals in FDA regulated industries, who are responsible for establishing, maintaining, operating a calibration program, and audit of calibration activities, including:- Quality Assurance
- Quality Control
- Quality Engineering
- Technical Support
- Research and Development
- Facilities and Equipment Maintenance
Description
The regulations covering manufacture and control of drug products and medical devices require that firms have a program for the calibration of test and measurement equipment. A requirement for calibration is also defined in ISO 9000 and a Quality System for a calibration laboratory is described in ISO 17025. Calibration is a good business and science practice followed in all industries that require measurements for process monitoring and control. The program must include the elements of: calibration intervals, scheduling, specific calibration procedures, limits of accuracy and precision and remedial action in the event that the instrument does not meet established requirements.
This course addresses the regulatory and business requirements for calibration as an element of a Quality System and how these requirements support the increasing application of process monitoring and sophisticated laboratory instrumentation, along with the maturing discipline of calibration in the regulated industries. It includes a discussion of a compliant calibration program and concludes with a discussion of a model calibration procedure.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Dr. Jerry Lanese; President, The Lanese Group, Inc.
John G. (Jerry) Lanese received a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. He moved from the academic environment to the pharmaceutical industry where he has worked for small and large pharmaceutical companies. Since 1994, Dr. Lanese has been an independent consultant in the area of cGMP compliance and has consulted with small and large medical device and pharmaceutical companies. As part of his consulting practice, he lectures on a variety of topics related to GMPs. Dr. Lanese is a member of the Editorial Board of the Journal of Validation Technology and the Executive Advisory Board of the Institute of Validation Technology. He has been active in the Kansas Award for Excellence program for the past eleven years and has served as Examiner, Lead Examiner and Judge.
In 2005, Dr. Lanese’s article “Training in the Laboratories” was selected as the Best Article of the Year by the Journal of GXP Compliance.
Joseph T. Busfield; Principal, Pharmaceutical Technical Services
Joseph T. Busfield is the Principal of Pharmaceutical Technical Services and has over 25 years experience in the food, pharmaceutical and biopharmaceutical industries. His responsibilities have included project engineering, validation, instrumentation, maintenance, and utilities for a sugar refinery, oral dose and parenteral pharmaceutical manufacturing facilities. His experience in operating plants includes design, start up, validation and operation.
Mr. Busfield is currently involved in several compliance projects with some clients under consent degree or other regulatory burden and others trying to avoid such problems. His major emphases are in maintenance and calibration programs in the regulated health industry as well as validation efforts. His activities are centered in the US, with activities in the UK and Israel. He holds a B.S., (Mechanical Engineering) from Drexel University, and a M.B.A., (Management and Finance), from LaSalle University. Mr. Busfield serves as an adjunct professor at several colleges teaching management and math courses.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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info@cfpa.com
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