ISPE Hands-On Commissioning & Qualification (C&Q), Process Validation, and ATMP Training
3-Day Training Event at the European Aseptic and Sterile Environment
10 - 12 SEPT 2024 | (EASE) Facility Strasbourg, France
To meet the challenges of a science and risk-based approach, while enhancing industry efforts to develop, manufacture, and reliably deliver quality medicines to patients, ISPE is conducting a 3-day training event in a unique setting, the European Aseptic and Sterile Environment (EASE) Facility in Strasbourg, France.
What to Expect?
Overview of EASE Facility
Commissioning & Qualification (C&Q), Process Validation, and ATMP Days 1, 2, and 3
The course will cover qualification and process validation, from EU and US perspectives, considering both small and large molecule aspects, plus it will include a half day to consider qualification and process validation for ATMPs.
The early part of the course will concentrate on ensuring understanding of patient drivers and manufacturing process steps. It will cover fundamentals for product and manufacturing processes and how the purpose and function of equipment, utilities and facilities relate to these, and hence the need for these systems to be appropriately qualified and validated.
It will cover details on EU and FDA guidance documents, and their application in validation/qualification, plus input on the relatively recently updated ICH Q9R1 on Quality Risk Management and how this impacts commissioning/qualification.
The course will explain the various steps for qualification and validation, including understanding the importance and key content for good User Requirements Statements (URS), followed by appropriate IQ (Installation Qualification), OQ (Operational Qualification) and continued/ongoing process verification (CPV/OPV). It will consider how much documentation should be produced by ‘client’ companies vs the information provided by engineering facility/ utility/ equipment suppliers and installers.
Finally, it will also cover process validation (PV) including the lifecycle from QTPP (Quality Target product profile), CQAs (Critical Quality Attributes) and CPPs (Critical Process Parameters), material attributes and how to determine the number of PV batches.
Included in the 3 days will be how these aspects impact ATMPs, be they autologous or allogeneic.
The training will include information and experience on this topic and will, as much as is possible, align to attendees’ particular requirements.
Attendees will have the opportunity to see inside the processing suite and visit the facility and its plant room.
Upon completing days 1, 2 and 3 of this event, you will:
Understand EU and US regulatory fundamentals for qualification and process validation.
Appreciate the importance of a science and risk-based approach, relating qualification/validation to patient/product/ process drivers.
Be aware of the new ICH guideline on Quality Risk Management (ICH Q9R1) in relation to qualification and process validation.
Receive explanation of the steps for qualification and process validation (e.g., URS/DQ/IQ/OQ/PQ/PV) and how they relate to each other for facilities, equipment, and utilities.
Consider how qualification impacts pharmaceutical products and processing for various product types (oral solids, liquids, sterile and ATMPs)
Discuss how to determine the number of process validation batches.
Engage in interactive discussions and exercises.
Attendees will receive a copy of ISPE Baseline guide Volume 5 on Commissioning and Qualification
Regulatory basics for US & EU
Overview of ISPE C&Q (Commissioning and Qualification) Guide
Product and process understanding
URS (User Requirements Statement) and DQ/IQ/OQ/PQ steps
Quality risk management & ICH Q9R1
Process Validation (PV)
Number of PV batches
C&Q/PV application to ATMPs
Alcon A/P - 6201 South Freeway
FORT WORTH, TX 76134
Who should attend this 3-Day hands-on training event?
Engineers, QA, manufacturing, validation/qualification personnel and suppliers wanting to know more about pharmaceutical qualification and validation, the steps involved, and the link from patient, products, and processes to qualification/validation, including:
Engineers responsible for design, project management or maintenance of pharmaceutical facilities, and their infrastructure
Manufacturing personnel, and managers/supervisors of production Quality assurance managers & supervisors
Vendors/suppliers and service organizations for pharmaceutical equipment, utilities, and facilities.
Engineering consultants involved in facilities and their qualification/validation.
Project/manufacturing engineering resources engaged in project execution.