Strengthen your understanding of FDA Process Validation Guidance, EU Annex 15, process qualification, lifecycle validation, and continued process verification.
Select live training or recorded access for an individual attendee or a group of up to five participants.
$1,495
Best for one participant attending live.
$4,995
Best for teams attending the live seminar together.
$1,298
Best for one participant who prefers on-demand access.
$2,895
Best for teams that need flexible viewing.
Understand Current FDA & EU Expectations for Process Validation, Qualification & Lifecycle Compliance.
Process validation continues to remain one of the most highly scrutinized areas during FDA and EU inspections. Regulatory agencies expect companies to demonstrate a lifecycle-based approach to qualification, validation, process monitoring, and ongoing compliance.
Understanding current FDA Process Validation Guidance and EU Annex 15 expectations is critical for maintaining compliant manufacturing operations and reducing regulatory risk.
This live instructor-led training is designed to help professionals strengthen their understanding of:
✔ FDA Process Validation lifecycle expectations
✔ EU Annex 15 qualification & validation requirements
✔ Process qualification and continued process verification (CPV)
✔ Risk-based validation approaches
✔ Validation documentation and compliance readiness
Participants will receive:
🎓 Professional Certificate of Completion
📘 Continuing education training hours
✔ Practical knowledge aligned with current FDA & EU validation expectations
Explore the complete two-day agenda for the Process Validation Guidance & Requirements Training Course, covering FDA expectations, EU Annex 15, process qualification, and continued process verification.
Join this practical two-day virtual seminar and gain a clear understanding of FDA and EU process validation expectations.
The following professionals will benefit from this FDA Process Validation Training:
✔ Quality Control (QC) Professionals
✔ Quality Assurance (QA) Specialists
✔ Project Managers
✔ Product Development Teams
✔ Regulatory & Compliance Professionals
✔ Manufacturing, Engineering & Facilities Personnel involved in validation activities
✔ Validation & Technical Services Professionals
✔ Professionals seeking to strengthen their understanding of process validation requirements, regulatory expectations, and compliance challenges
Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, GLP/GMP, quality control, auditing, microbiology consulting, expert witness, sterility assurance, microbiological/analytical validations and fermentation technology.
As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.
Q1. Who should attend this seminar?
A1. This program is ideal for professionals in Quality Assurance, Quality Control, Regulatory Compliance, Project Management, Product Development, and Biopharmaceutical Manufacturing, as well as those seeking to strengthen their understanding of FDA process validation requirements.
Q2. What will I learn from this training?
A2. You will gain a practical understanding of FDA and EU guidelines on process validation, lifecycle approaches, risk-based strategies, documentation practices, and compliance techniques tailored for biopharmaceutical manufacturing processes.
Q3. Is the seminar interactive?
A3. Yes. The virtual format includes live presentations, case studies, and Q&A sessions to ensure participants can clarify concepts and apply them to real-world scenarios.
Q4. Will I receive certification?
A4. Yes. All participants will receive a Certificate of Completion, which can support professional development and compliance training records.
Q5. Do I need prior knowledge of process validation?
A5. No prior in-depth expertise is required. The course is structured to benefit both beginners and experienced professionals by covering foundational principles as well as advanced regulatory updates.
Q6. How will this training benefit my organization?
A6. By attending, your team will be better equipped to design, execute, and document validation processes, reduce compliance risks, and improve overall product quality and regulatory readiness.
“Highly Practical and Insightful”
This seminar provided exactly what I needed – clear explanations of FDA requirements and practical examples I could apply immediately in my work. The trainer’s expertise in biopharmaceutical manufacturing was outstanding.
— QA Manager, Biotech Firm
“Excellent Balance of Theory and Real-World Application”
The course covered regulatory guidelines in detail but also gave us real-world case studies, which made complex concepts much easier to understand. I feel more confident handling validation projects now.
— Senior Process Engineer, Pharmaceutical Company
“Engaging and Well-Structured”
Even though it was virtual, the sessions were highly interactive. The Q&A sessions and case discussions helped me clarify doubts and gain deeper insights into compliance challenges.
— Regulatory Affairs Specialist
