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Short Course

Course Information
Course Title: Qualification of Analytical Instruments for the Pharmaceutical Laboratory
Categories: 1 - Analytical Metrology
2 - Liquid Chromatography
3 - Pharmaceutical Sciences
4 - Gas Chromatography
5 - Validation
Instructor(s): Gregory Martin Course Number: 165
Affiliation: Complectors Consulting
Course Date: 03/21/2013 - Thursday Course Length: 1/2 Day Course
Start Time: 08:30 AM End Time: 12:30 PM
Fee: $260 ($360 after 2/18/13) Textbook Fee:

Course Description
This half-day course is designed to provide participants with an understanding of the need for qualification of instruments in the pharmaceutical laboratory, and practical information about how to implement a successful instrument qualification program designed to meet scientific needs and regulatory inspection expectations. The course will describe the steps in the qualification process, using USP <1058> as a guideline, and the roles and responsibilities of various groups in this process. A recent stimuli article proposing an integrated approach to instrument qualification and computerized system validation will also be discussed. Change control will be discussed, including addressing maintenance, preventative maintenance and periodic requalification. There will also be discussion on what to expect, related to instrument qualification, during a regulatory inspection.

Target Audience
Laboratory personnel responsible for analytical instruments, managers of analytical or Quality Control Laboratories, Metrologists and Quality Assurance personnel responsible for assuring compliance with instrument qualification requirements.

Course Outline
1. The basis for requiring qualification of analytical instruments
2. The analytical instrument qualification process
a. Design Qualification
b. Installation Qualification
c. Operational Qualification
d. Performance Qualification
3. The roles and responsibilities of various groups
4. The relationship between qualification and system suitability or quality control check samples
5. Stimuli article on integrating analytical instrument qualification and computerized system validation
6. Documentation
a. Practical examples for common laboratory instruments
b. Change Control
c. Maintenance, Preventative Maintenance, Requalification
7. What to expect from an FDA inspection of analytical instruments
8. Attendee Questions and Discussion

Course Instructor's Biography
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group. He can be contacted at greg.martin@complectors.com.