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.

Interactive workshops on:

• instrument criticality assessment
• instrument accuracy and uncertainty ratios
• calibration certificate review and auditing
• temperature measurement and calibration
• pressure measurement and calibration
• balance accuracy and minimum weight specifications
• calibration failure capa investigation

Distinguished Faculty

Geoffrey Marsden P.Eng
Principal, MGN 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.

Who Should Attend

This Two-day course is valuable for Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

• Calibration
• Technical support
• Engineering
• Manufacturing
• Maintenance
• Quality Assurance
• Quality Control Laboratory
• Analytical Laboratory
• Contract Laboratory
• Validation
• Regulatory Affairs
• Project Management
• Training
• Consultant