The guide was first issued in and reflective of that time. With emerging markets, changes in the regulatory This Guide provides practical guidance on the implementation of a science and risk-based approach for the commissioning and Baseline Guides. Good Practice Guides.
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The successful delivery of manufacturing facilities , including small, large, new, expansion, or renovation type projects regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers.
These facilities are required to meet all applicable GxP regulations, and to comply with all other relevant local and international governing codes, laws, and regulations. This classroom course is designed to improve the way in which the industry delivers regulated manufacturing capacity: improving the ability to meet documented process requirements, control risks within the manufacturing process, produce high-quality products and consistently operate to meet product and process requirements.
Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory. Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach to Quality Risk Management.
This course will be of interest to those following the latest industry and regulatory initiatives, including application product and process understanding within qualification and the science- and risk-based approach with emphasis on commissioning and qualification of equipment and systems.
Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18, pharma professionals from around the world by becoming an ISPE Member.
Overview The successful delivery of manufacturing facilities , including small, large, new, expansion, or renovation type projects regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers.
Learning Objectives 1. Discuss the information necessary to develop Requirements Documents that will support a science and risk based approach to qualification. Risk Assessment: Apply risk management methodologies throughout design and verification phases. Explain the link between risk assessments, design review, and quality risk management. Testing: Understand and examine the development of a Verification Strategy that incorporates use of vendor testing, construction quality assurance, site acceptance testing, installation checks, and functional testing.
Evaluate Implementation and range of options for documenting Design Review including One Page Memo; Traceability Matrix, Pre approved protocol, and detailed documentation of detailed design review sessions. Know what is involved in a system Acceptance and Release report given requirements, critical aspects, and verification test results in compliance with a verification strategy.
Change Management: Define change management strategies to adjudicate planned departures from requirements and specification. Who Should Attend Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory.
This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information. Commissioning and Qualification. ISPE Membership Benefits Become a member today Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18, pharma professionals from around the world by becoming an ISPE Member.
ISPE publishes revised Guideline on Commissioning and Qualification
Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning and Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2 nd Edition Guide, ICH documents Q8 R2 , Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E Guidance is provided how to transition an organization's approach quality systems and establishing the appropriate of level of quality oversight for Commissioning and Qualification that incorporates a science and risk-based approach. NOTE: It is strongly recommended that participants be familiar with basic concepts of commissioning and qualification prior to attending this course. This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course.
Commissioning and Qualification
By Steve Wisniewski , July 16, The revised Guide provides the current industry best practices for commissioning and qualification of pharmaceutical facilities and equipment. This guide defined a better understanding of baseline cGMP requirements through coordination with ISPE, industry, and global regulatory bodies. The guide defined a flexible and innovative lifecycle approach to facility, systems and equipment design, construction, commissioning, and qualification supported by the definition of key terms for consistent interpretation and application.