Equipment and Utilities Qualification
Independent Consultant, JEM Consulting Services Inc
San Francisco, CA
Independent Consultant, JEM Consulting Services Inc
Equipment and utilities used in regulated manufacturing environments shall be qualified to demonstrate suitability for the intended use. Despite that equipment and utilities qualification is nothing new and companies spend a lot of resources on it, it is a frequently cited deviation in FDA and EMA observations. Sometimes companies are unsure on what to qualify, test and document.
The qualification of equipment and utilities for sterile, oral solid dosage forms, liquids, and bulk drugs (among others) in the pharmaceutical and bio-pharmaceutical manufacturing is indispensable for process validation. Equipment and utilities must be installed, operated and maintained within design specifications.
CGMP regulations and auditors deem qualified equipment and utilities as a prerequisite for process validation. The identification of the equipment that needs to be qualified by way of a risk analysis is a critical milestone. Equipment and utilities have considerable attention as the regulatory environment is evolving due to updated initiatives by the FDA and EMA. This seminar provides a demonstration of the practical application of the science and risk-based approach to qualification of these updated regulations.
In this two day seminar you will learn the expectations of equipment and utilities qualification along with the development of a sound qualification program in order to develop and implement cost-effective solutions that are accepted, effective, and efficient. Through the seminar we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Also, we will explore how your management practices of your equipment and utilities qualification programs can help or hurt on the issues that arise from non-conformance with regulators and auditors.
In addition, I explain how equipment and utilities qualification must meet regulatory requirements using means such as risk management, statistical analysis and change management. This seminar presents you how to plan, perform and document qualification activities to new and existing equipment and utilities in an efficient and effective way.
You will learn how to:
Jose E. Martinez, MS (Microbiology & Biochemistry), MT (ASCP), is a pharmaceutical / biotechnology / medical devices consultant and validation project manager, who specializes in validation, qualification, technology transfer, and microbiology. He has over 32 years of experience in validation, technical services, quality assurance/control and microbiology departments. His experiences are broad, from hands-on to managerial positions. Have hosted over 30 audits from customers and regulatory bodies (FDA, MCA, EMA and TGA) and have performed audits in Puerto Rico, the continental USA and in Central America. Have published 10 articles in peer-review journals such as Pharmaceutical Technology and Bio Process International. In addition, have authored two book chapters: 1. John Wiley & Sons’ text / reference book, "Advance Techniques in Instrument Qualification, Performance Verification and Analytical Method Validation", 2010; and 2. Manual de Microbiología aplicada a las Industrias Farmacéutica, Cosmética y de Productos Médicos, “Control de la Validación de un Proceso de Saneamiento”, Asociación Argentina de Microbiología (AAM), 2013, (Revised and republished in 2019). Coauthored the ASTM Standard WK11898, “Practice for Real-Time Release of Pharmaceutical Water for The Total Organic Carbon Attribute”, 2010. Main speaker in seminars at South and Central America, Puerto Rico and the continental USA.
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