| |
|
|
|
CfPA - The Center for Professional Advancement, East Brunswick, NJ
January 29-30, 2014
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
• Engineering Maintenance
• Calibration Description
US and European regulations covering manufacture and control of drug products and medical devices require that firms have a program for the calibration of test and process 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 the application of risk to instrument classification and concludes with a discussion of a model calibration procedure.
|
|
|
|
|
|
|
|
Organized by:
|
|
CfPA - The Center for Professional Advancement |
|
|
Invited Speakers:
|
|
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 18 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. Jerry is a member of the Editorial Advisory Boards of the Journal of GXP Compliance and is the co-author of a column, “GXP Talk” that appears in each issue of this Journal.
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 regularly involved in several compliance projects with clients under consent decree 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 has served as an adjunct professor at several colleges teaching management and math courses.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
n/a
|
|
|
|
|
|
|
|
Registration:
|
|
Please click here for registration information.
|
|
|
E-mail:
|
|
sberg@cfpa.com
|
|
|
|
|
|
|
|
|