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CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
9-10 December 2013
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 and 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, developed and presented by Dr. John (Jerry) Lanese and Joseph Busfield, calibration experts, 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.
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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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Dr. Jerry Lanese; Pharmaceutical Quality & Technology Consultant
Dr. Jerry Lanese, an International Pharmaceutical Industry Consultant, has a Ph.D. in Analytical Chemistry from the University of Michigan. He began his career teaching Analytical Chemistry at the college level. He moved to industry where he has gained more than 30 years of quality control, quality assurance and analytical research experience in the pharmaceutical industry. He has worked in large and small pharmaceutical firms managing Analytical Research & Development and QA & QC functions. Dr. Lanese was the quality representative on the team that started manufacturing operations in Puerto Rico for a major pharmaceutical firm. For the past 17 years, he has been a consultant in the drug and medical device industries focusing on laboratory activities, performing quality assessments and helping both small and large firms to achieve a higher level of compliance. Dr. Lanese has been part of several teams working with firms under consent decree. Dr. Lanese is a member of the ASQ, and the Editorial Advisory Boards of and Journal of GXP Compliance.
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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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sberg@cfpa.com
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