{"id":1058,"date":"2013-04-02T14:17:42","date_gmt":"2013-04-02T18:17:42","guid":{"rendered":"http:\/\/easinc.org\/wordpress\/?p=1058"},"modified":"2013-05-20T16:03:06","modified_gmt":"2013-05-20T20:03:06","slug":"e13-qualification-of-analytical-instruments-for-the-pharmaceutical-laboratory","status":"publish","type":"page","link":"https:\/\/eas.org\/2024\/e13-qualification-of-analytical-instruments-for-the-pharmaceutical-laboratory\/","title":{"rendered":"E13 – Qualification of Analytical Instruments for the Pharmaceutical Laboratory"},"content":{"rendered":"
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Qualification of Analytical Instruments for the Pharmaceutical Laboratory<\/b><\/span><\/p>\n<\/div>\n

New One-Day Course E13-12, Sunday, November 17th, 8:30am – 5:00pm<\/span><\/i><\/b><\/p>\n

Mr. Gregory Martin, Complectors Consulting, Pottstown, PA<\/p>\n

COURSE DESCRIPTION
<\/span><\/b>This interactive 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.\u00a0 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.\u00a0 We will touch on requirements for instruments with firmware or instrument control, although the validation of stand-alone software is outside the scope of this course.\u00a0\u00a0 Examples of documentation will be provided, with practical suggestions for some common laboratory instruments.\u00a0 Change control will be discussed, including addressing maintenance, preventative maintenance and periodic requalification.\u00a0 There will also be discussion on what to expect, related to instrument qualification, during a regulatory inspection.\u00a0\u00a0<\/p>\n

There will be ample opportunity for questions and discussion.\u00a0 Upon completion of this course the learner should be able to:
1)\u00a0\u00a0\u00a0\u00a0 Understand the rationale for instrument qualification.
2)\u00a0\u00a0\u00a0\u00a0 Be familiar with the contents and intent of USP General Chapter <1058> and related information in USP.
3)\u00a0\u00a0\u00a0\u00a0 Identify and address the various steps in the qualification process:\u00a0 design qualification, installation qualification, operational qualification and performance qualification, and understand the differences between the steps.\u00a0 Be able to draft a qualification protocol.
4)\u00a0\u00a0\u00a0\u00a0 Understand he rationale for preventive maintenance, periodic calibration\/requalification and change control. Be able to design an instrument inventory that will be useful throughout the life of the instruments.
5)\u00a0\u00a0\u00a0\u00a0 Effectively prepare for a regulatory inspection of their analytical instruments<\/p>\n

WHO SHOULD ATTEND
<\/span><\/b>Laboratory personnel (pharmaceutical quality control or research and development, contract labs, OTC or nutraceuticals) responsible for analytical instruments, managers of analytical or Quality Control Laboratories, Metrologists and Quality Assurance personnel responsible for assuring compliance with instrument qualification requirements.<\/p>\n

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TOPICS
<\/b><\/span>1. Assessment of Participants Needs
2. The Basis for Requiring Qualification of Analytical Instruments
3. Hands on Activity:\u00a0 Designing an Instrument Inventory
4. The Analytical Instrument Qualification Process
\u00a0\u00a0\u00a0\u00a0 * Design qualification
\u00a0\u00a0\u00a0\u00a0 * Installation qualification
\u00a0\u00a0\u00a0\u00a0 * Operational qualification
\u00a0\u00a0\u00a0\u00a0 * Performance qualification
5. Hands on Activity:\u00a0 Designing DQ\/IQ\/OQ\/PQ Protocols\u00a0for a Lab Instrument
6. The Roles and Responsibilities of Various Groups
7. The Relationship Between Qualification and System Suitability or Quality Control Check Samples
8. Scope of USP\u00a0 General Chapter <1058>
\u00a0\u00a0\u00a0\u00a0\u00a0* Software controls
\u00a0\u00a0\u00a0\u00a0 * Instrument categories
9. Documentation: Practical Examples for Common Laboratory Instruments
10. The Rationale for Preventive Maintenance, Periodic Calibration\/Requalification and Change Control
11. Hands on Activity:\u00a0 Revisit the Instrument Inventory
12. Hands on Activity:\u00a0 Change Control for Lab Instruments
13. Change Control:\u00a0 Maintenance, Preventative Main-tenance, Requalification
14. What to Expect from a FDA Inspection of Analytical Instruments:\u00a0 Common Citations for Instruments During Regulatory Inspections
15. Attendee Questions and Discussion<\/p>\n<\/div>\n<\/div>\n

<\/a>ABOUT THE INSTRUCTOR
<\/span><\/b>Mr. Greg Martin <\/b>is President of Complectors Consulting\u00a0which provides consulting and training in the area of Pharmaceutical Analytical Chemistry.\u00a0 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.\u00a0 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.\u00a0 In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters \u2013 Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.\u00a0 He is also Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.\u00a0 Mr. Martin is co-author (with Vivian A. Gray) of the series \u201cDissolution Concepts and Applications\u201d which has appeared in Journal of Validation Technology and Journal of GXP Compliance.<\/p>\n

\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"

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