Validation & Verification of Analytical Procedures
Days
Hours
Minutes
Seconds
This course includes:
-
Collaborative environment that
encourages interaction - Case studies and Q&A sessions
- Training materials
-
Tools and techniques to apply
immediately in your role - Recording access
- Certificate of completion
Course outline
Validation and verification of analytical procedures are essential to ensure the accuracy, precision, and reliability of drug testing methods. With the latest updates in ICH Q2(R2) and the introduction of ICH Q14, regulatory expectations have evolved, requiring a deeper understanding of analytical performance and statistical evaluation.
This three-day masterclass will provide a comprehensive guide to designing, executing, and interpreting analytical validation and verification studies. Participants will learn best practices for method validation, establishing acceptance criteria, and using statistical tools to enhance analytical quality.
Key Takeaways
- Master the latest updates in ICH Q2(R2) & Q14 and their impact on validation.
- Design effective validation and verification studies using risk-based approaches.
- Optimize accuracy, precision, and calibration models through advanced statistical methods.
- Understand lifecycle concepts and regulatory requirements for analytical procedures.
- Apply Quality-by-Design (QbD) principles for method development and validation.
Who Should Attend?
- Quality Control & Quality Assurance Managers
- Regulatory Affairs & Compliance Professionals
- Analytical Development & Validation Scientists
- Pharmaceutical & Biopharmaceutical Scientists
- Laboratory Managers & Analytical Chemists
- GMP & Compliance Experts
Agenda Highlights
Day 1: Fundamentals of Analytical Validation & Regulatory Requirements
- ICH Q2(R2), Q14, USP & FDA guidelines
- Understanding analytical performance & validation characteristics
Day 2: Practical Application & Statistical Approaches
- Precision, accuracy, specificity & calibration models
- Statistical evaluation of analytical procedures
Day 3: Lifecycle Management & Verification of Compendial Procedures
- Detection & quantitation limits, compendial methods & GMP compliance
- Utilizing development data for efficient validation
About Trainer
Dr. Joachim Ermer is a renowned expert in analytical validation and quality control with over 30 years of experience in pharmaceutical analysis, method development, and GMP compliance. He has held senior roles in global pharmaceutical companies, is a member of the Ph.Eur. and USP Expert Committees, and has authored over 70 publications on analytical validation.
Request Agenda
Companies Represented By Our Participants
Proud Stories
★★★★★
Marsha Miller
Pragmatic approaches and clarification on when statistics is useful and when not. Perfect guidance through the official guidances out there and pointing out where they are sometimes contradictory and therefore confusing during application in daily work. Very honorable teacher and very good at making complex things understandable. As the head is spinning after such intense training, the hand-outs and workshop documentation given will help in having the learned content re-called
★★★★★
Michael Durschlag
James provided a comprehensive, detailed, and complete view of Annex 1 updates, tied it to QRM and to PICS guidance. He delivered the material in an easy-to-understand format, and we did not experience any problems with the streaming. The slide material provided will be very useful as a reference.
★★★★★
Nancy Musik
This was a very in-depth training, and I especially appreciated the real-life examples or possible solutions and real industry examples and mitigation approaches. Trainer definitely a SME on this subject and was able to provide lots of information and background details to explain Annex 1 intentions.
★★★★★
Vyara Kuneva
The training offered a large scope of relevant information, presented in an understandable and interesting way. The hands-up approach, supported by examples and simulations makes the content easy to understand and remember. The lecturer was excellent, and the course was very well organized.
★★★★★
Walter Drexler
I have never seen such an extensive session on statistics for practitioners on all these burning topics provided. It basically covers all of them we also discuss in our company. A great spectrum of topics covered.
★★★★★
Seth Byers
Well organized presentation, very knowledgeable presenter, great atmosphere
★★★★★
Hassan Abdu Al Asmary
Touched my needs, Mr. James is a wonderful lecturer who made it easy and clear.
★★★★★
Gabriela Saucedo
The facilitator and expert, the documents shared, the excellent facilitation skills of James and being engaged in the session.
★★★★★
Vassia Papakonstantinou
I really liked the flow of the presentation, and the way modules were explained using the appropriate ICH references
★★★★★
Nereus Jethro Abad
I enjoyed the class and found it informative, engaging and filled with valuable insights.
What you'll get?
-
Collaborative environment that
encourages interaction - Case studies and Q&A sessions
- Training materials
-
Tools and techniques to apply
immediately in your role - Recording access
- Certificate of completion
Related Events
Pharmaceutical
Statistical Methods for Process Validation
- February 26th - 28th 2025
- 9.00 am - 1.00 pm EST (UTC- 5)
Pharmaceutical
Good Documentation Practice in the GMP Environment
- February 26th - 27th 2025
- 9.00 am - 1.00 pm CET (UTC+1)
Pharmaceutical
Statistics for Quality Control & Quality Assurance Practice US
- March 17th - 19th 2025
- 9.00 am - 1.00 pm EDT (UTC- 4)
