Author
Walid El Azab
Attendees:
This program is designed for professionals involved in the development, qualification, and lifecycle management of pharmaceutical manufacturing processes. Key attendees include personnel from Validation, Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Research & Development (R&D), MS&T (Manufacturing Science & Technology), and Project Management.
Abstract:
This intensive three-day workshop delivers a comprehensive and practical exploration of the modern process validation lifecycle, aligned with ICH Q8-Q12 and global regulatory expectations. Moving beyond traditional compliance, the program embeds science- and risk-based principles to equip professionals with the skills to ensure robust product quality from development through commercialization. The curriculum is structured around the three-stage validation model: Day One focuses on Stage 1 (Process Design), where participants will learn to define QTPP, CQAs, and CPPs using QbD and risk assessment tools. Day Two delves into Stage 2 (Process Qualification), covering facility readiness, technology transfer, and the strategic execution of PPQ with an emphasis on statistical rigor and protocol development. Day Three addresses Stage 3 (Continued Process Verification) and lifecycle management, teaching attendees how to implement effective monitoring programs, manage changes, and drive continuous improvement. Through hands-on case studies simulating New Product Introduction and Legacy Product compliance, participants will collaboratively generate essential documents such as risk assessments, PPQ protocols, and CPV plans. By integrating ICH Q10 Pharmaceutical Quality System principles, this workshop provides the actionable knowledge and tools needed to design, qualify, and maintain validated processes, ensuring regulatory readiness and product excellence throughout the entire product lifecycle.
Learning Objectives:
Upon completion, participants will be able to:
- Articulate the modern, risk-based lifecycle approach to process validation as defined by global regulatory bodies (FDA, EMA, ICH).
- Apply Quality by Design (QbD) principles to define a Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), and establish a control strategy during the Process Design stage.
- Develop and justify a science-based strategy for Process Performance Qualification (PPQ), including protocol development, batch number justification, and statistical data analysis.
- Design and implement a Continued Process Verification (CPV) program to ensure ongoing process control and facilitate continuous improvement throughout the product lifecycle.
- Generate key validation documents and manage technology transfer activities for both New Product Introduction (NPI) and Legacy Products, ensuring robust regulatory compliance.
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