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.
Learning Objectives:
You will learn how to:
- Identify the FDA and EMA equipment and utilities qualification requirements.
- Develop a practical Qualification Master Plan and/or SOP.
- Assemble an effective project team including assignment of roles, responsibilities, and reporting structure.
- Examine the critical requirements for a project based on cGMPs and user requirement specifications.
- Execute an effective enhanced FAT or SAT to reduce the qualification work.
- Develop a content outline of the commissioning and validation master plans.
- Generate test plans for each equipment and utilities to specify how commissioning and qualification will be implemented and use the plans in the development of qualification protocols.
- Prepare an outline of the qualification protocol contents for provided systems and equipment based on user requirement specifications and actual design.
- How to develop the purpose and contents of equipment and utilities qualification phases.
- Requalify after equipment and utilities changes.
- Identify the best approach for automated systems.
- How to implement the lifecycle approach from the design, the qualification and the maintenance of equipment and utilities.
Areas Covered:
- Equipment qualification.
- Utilities qualification.
Who will Benefit:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Validation engineers
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
- 8:30 AM - 8:59 AM Registration Meet & Greet.
- Session will start at 9 AM
- Morning:
- Applicable Regulations
- Formation of the Project Team
- Master Qualification Plan / Qualification SOP
- User Requirements Specifications
- Benefits:
- Will learn which regulations apply based on the intended use of the equipment and utilities.
- Organizing workers into project teams lets you assign designated employees to specific sets of tasks. It also allows you to train selected individuals to perform these tasks. When people work as team, they understand the roles and responsibilities of the other team members.
- Understand and know how to write and maintain a Qualification Master Plan and/or SOP.
- Functional Requirements Specifications are required to protect both the end user and the manufacturer.
- Afternoon:
- Design Specifications
- Design Qualification
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Benefits:
- Attendees will understand that a design specification is a statement of how a design is made (specify the design), what it is intended to do, and how far it complies with the user requirements. Design qualification is part of the equipment life cycle.
- Development of FAT and SAT that will reduce the qualification work.
- Morning:
- Commissioning
- Installation Qualification
- Operational Qualification
- Benefits:
- Commissioning is a vital aspect and stage of the life cycle of any equipment and utility, which makes it extremely important to ensure it is completed before qualifications begin.
- Attendees will learn why installation and operational qualifications are critical and the importance of performing them.
- Afternoon:
- Performance Qualification
- Myths of Equipment Qualification
- Standard Operating Procedures (SOPs) Development
- Examples of FDA’s form 483 findings for equipment qualification
- Questions and Answers
- Benefits:
- Attendees will learn that performance qualification is analogous to process validation and when it can be omitted.
- There are many myths prevailing in pharmaceutical industries in view of equipment qualification either due to lack of knowledge or misinterpretation of regulatory guidelines which need to be known to avoid them.
- Attendees will learn to develop qualification SOPs that after the qualification work is completed will be implemented as regular SOPs.
- By means of FDA’s form 483 findings attendees will see why the agency expects definitive evidence that the equipment / utilities qualifications will satisfactorily control their manufacturing processes.
Jose E Martinez,
Independent Consultant, JEM Consulting Services Inc
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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