QbD, Scale-Up, Validation: The Lifecycle Management
- Real Time Online Delivery – Live Training Sessions
- Virtual Attendance for 4 Days Training
- Guided Learning Hours – 16
- Practical Exercises, Case Examples, Q & A
- Pre-Course Access: Orientation Session Coupon, Pre-Event Questionnaire, Presentation Slide Deck
Course Overview
This 4 Day Online Course aim is to provide an insight into the pharmaceutical product & process lifecycle concept. The course covers both small and large molecules, i.e both biotech process (upsteam, downstream), chemical pharmaceutical API and drug products and is based on EU and US regulations supported by ICH.
The foundation for the course is the lifecycle concept to process validation that links product and process development, qualification/validation of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production as well as continual improvement and lifecycle maintenance.
The Daily Sessions will discuss pharmaceutical process development using QBD principles, establishing the control strategy, transfer of the process into commercial operations, validating it and being able to execute it for routine production – product realization (manufacture and release products). High attention will be on the Quality by Design approach and the establishment of the Control Strategy that drives scale-up, technology transfer, qualification, validation, commercial operation and continual improvement.
The Daily Sessions further focus; to establish the control strategy a supportive Pharmaceutical Quality System must be in place including Quality Risk Management tools, Process Analytical Technology support and Design of Experiment skills. During the course you will be introduced to these elements and they will be linked through practical group exercises.
The course will be interactive with a combination of course lectures and group exercises.
Trainer’s Profile
Our Expert Trainer has experience of 20+years in the pharmaceutical industry.
A consultant, specialised in the science & risk-based concept of pharmaceutical development and manufacturing including quality by design (QbD), process analytical technology (PAT), process validation lifecycle (PV), good manufacturing practice (GMP), quality risk management (QRM) and the related regulatory & compliance aspects. Over the years held various management & specialist portfolios; head of QC, PAT and QBD, technology transfer assignment with innovator & generic companies and pharma industries 4.0 projects involvement of late.
An expert in implementing a lifecycle approach to process validation, active in shaping the international QBD concept based on ICH Q8-11 guidelines. 15+ years association with ISPE including being the chair of PQLI control strategy team. One of the co-authors of the ISPE PQLI good practice guide (2011), a well respected speaker & trainer at different conferences, seminar & workshop.
Key Takeaways
- The lifecycle approach to validation including the regulatory expectations
- The science and risk-based approach to pharmaceutical development and process design
- How to apply QbD principles for process design, qualification and control
- How Design of Experiments and PAT helps to gain process understanding
- Quality Risk Management principles and tools and why they are important
- How to establish an ongoing process verification program for new and legacy products
Who Should Attend
- Pharmaceutical Development
- Process Design
- Process Qualification and Validation
- Process Control
- Process Support
- Process Engineering
- Ongoing process verification and improvement of manufacturing processes
- Development Scientific Professional
- Technical Support Management
- Technology Transfer
- Manufacturing Supervisor/Engineer/Manager
- Quality Control / Assurance
- Regulatory Affairs
- Validation Specialist
For participation details contact
Samuel Isaac
+1 786 633 1223(Canada)