Calibration Program – Design, Documentation, and Management
Details
The first part of the course begins by reviewing the regulatory requirements for calibration in the pharmaceutical industry. It then moves on to describe the management of calibration covering such items as:
- calibration definitions and terminology
- criticality assessment
- effective calibration policies and procedures
- calibration equipment
- instrument management
- calibration management software
- calibration and the CAPA (Corrective Action and Preventive Action) process.
- instrument records management & documentation
- training
- vendor control and approval
- auditing
The second part of the course consists of a series of topics, interactive exercises and group discussion related to the calibration of specific types of instruments used in pharmaceutical facilities, processes and laboratories.
This part of the workshop will emphasize practical issues and will cover:
- instrument technology
- facilities instruments
- process instruments
- laboratory instruments
- instrument specifications
- metrology methods
- pharmaceutical industry specific calibration requirements
- calibration problem solving
- design of equipment for calibration
The course provides multiple opportunities for group discussions, case studies and exercises. Participants are encouraged to bring any calibration issues they have to the workshop for discussion.
The course provides participants the opportunity to gain the skills and knowledge necessary to meet the FDA, Health Canada’s and other regulatory agencies’ expectations.
Outline
Speaker/s
PrincipalMGN Engineering Inc.
Over 15 years specializing in pharmaceutical industry calibration has given Geoff the opportunity to work with companies such as GSK, AstraZeneca & Biovail, Novocol, Wellspring, Aventis Pasteur, & Apotex.
Currently the principal of his own engineering firm, Geoff continues to work with leading pharmaceutical companies providing calibration & validation services, training and consulting.
Geoff was educated in the United Kingdom and Canada. He is an Ontario licensed professional engineer and holds a degree in Electrical Engineering & Management from McMaster University in Hamilton, Ontario.
Schedules
| No. of Days: | 2 |
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If you are looking for a college that offers challenging programs in high demand fields, such as Pharmal, Biopharma, healthcare, Food, Medical Devices, Cosmetics, and Environmental AAPS is the place for you. Don't wait for life's rewards to come around - Make it happen by getting the education you need.
AAPS is the Canadian premier Life Sciences and Pharmaceutical training college. The school was established in 2003 to address the growing demands by healthcare manufacturers for better prepared and more practically trained applicants. In tailored response, AAPS was designed and made operational by a team of highly experienced industry experts with one mission in mind; to create professional skill development programs that would exceed industry-training standards".
Employing only leading industry professionals with decades of experience, AAPS is setting the standard for pharmaceutical, food and healthcare training and career advancement. These experts continually develop and update the diploma programs and certificate courses at AAPS to meet the rigorous demands of the industry. ...
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