Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification (T40)

Level: Intermediate
ISPE CEUs: 1.5
Type: Classroom Training Course
Includes Webinar

Description

Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8, Q9, and Q10 and ASTM E-2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process; producing high quality products and consistent operation to meet product user requirements. Guidance on the transition of an organization’s approach to Commissioning and Qualification to one that incorporates a science and risk-based approach will be discussed.

This course was developed by members of the ISPE Commissioning and Qualification COP.

NOTE: It is strongly recommended that participants be familiar with basic concepts of commissioning and qualification prior to attending this course.

Includes Webinar 

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.

Implementing ASTM Standard for Verification

Description:

Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E 2500-07 ensures GMP facilities and equipment are "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. This webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle

At the conclusion of this Webinar, participants will be able to:

• Relate the ASTM Standard to GMP regulations and guidance documents
• Explain the regulatory foundation for the risk-based approach
• Understand the 2001 ISPE Baseline^® Guide: Commissioning and Qualification and how it links to new concepts in the ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
• Differentiate qualification versus verification
• Differentiate between the new risk assessment approach versus the old one
• Understand how the new draft USFDA Process Validation Draft links to ASTM E 2500
• Understand the details on verification process flow
• Implement verification through the C&Q process (FAT, SAT, IV, FV, PT)
• Understand ways GEP can be used as a foundation for verification

Take Back to Your Job

• Explain the relationship between ICH Q9, ASTM E-2500, ISPE Guide: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment and the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification.
• Discuss the information necessary to develop Requirements Documents that will support a science and risk based approach to qualification. Given the necessary information and a list of requirements, identify those that are necessary for product quality and those that are business / safety related.
• Apply risk management methodologies throughout design and verification phases. Explain the link between risk assessments, design review, and quality risk management.
• 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.
• 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.
• Outline the use of GAMP^® 5 principles in support of system delivery of a packaged system inclusive of mechanical and control system elements.
• Summarize US / EU / SFDA / and WHO regulatory requirements and expectations that may influence application of a science and risk based approach.

Attendance Suggested For

• Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach.
• Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the following ISPE Communities of Practice (COP):

• Commissioning and Qualification

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency element Facilities and Equipment: Commissioning and Qualification. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.