ISPE CEUs: 2.0
Type: Classroom Training Course
Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should I make? Are we taking enough samples? Do we need to use statistics in our protocols? The real question may be: am I even focusing on the right questions?
Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry.
This classroom course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System. It will provide you with practical application of quality risk management tools in preparation and planning for validation of your manufacturing control strategy. It will deliver statistical approaches and tools which can be used to strengthen and justify your decision-making rationale for defendable process design and process performance.
This course will trace the evolution of Process Validation from it’s infancy in the 1980’s to its current state of maturity. The level of evolution is evidenced with so many relevant guidance documents: ICH Q8, Q9, Q10 and Q11, the upcoming Q12, the 2011 US FDA guideline on Process Validation, EMA’s Process Validation documentation (general PV guideline, Annex 15, and biotech products). Now more than ever, there is a need to understand that process validation should be considered a science- and risk-based, life cycle activity rather than a one-time event of manufacture of three commercial scale batches. Companies should demonstrate that processes in the commercial phase of the lifecycle are maintained in a state of control using these techniques.
Note: This course will not cover formulation development, the regulatory submission processes or detailed engineering designs and associated qualification.
Day 1 - Overview of Stage 1: Process Development
Day 2 - Stage 2: Performance Qualification / Process Validation
Day 3 - Stage 3: Continued Process Verification / Ongoing Process Verification
Take Back to Your Job
Who Should Attend
This course is relevant to individuals involved in process validation of products and processes in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management.
Specific job functions include:
Development, manufacturing, engineering, quality, validation compliance, and scientific professionals with intermediate level experience in development, manufacturing, engineering, validation, quality, technology transfer and those wishing to understand the concept of process validation as a lifecycle.
Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients, Commissioning and Qualification, Critical Utilities, Oral Solid Dosage, Process Analytical Technology, Product and Process Development, Sterile Communities of Practice (COPs).