Included with Registration
- Presentation Slides
- Certificate of Completion
- Live Q&A with Expert
- 10 hours of Continuing Education
- Case Studies
- Real-World Examples
This training provides a practical, step-by-step approach to analytical method validation, verification, and transfer - helping you implement compliant methods, strengthen documentation, and avoid common pitfalls seen during audits and regulatory reviews.
By attending this training, you will be able to:
- Develop and validate analytical methods with confidence
- Meet FDA, ICH, and global regulatory expectations
- Avoid common validation and documentation errors
- Handle OOS (Out-of-Specification) results effectively
- Execute method transfer between laboratories successfully
- Generate reliable and audit-ready analytical data
Why this training is important
- Regulatory agencies require validated analytical methods for product approval
- Poor validation practices can lead to audit findings and delays
- Many teams face challenges with method transfer, documentation, and compliance
Course Content
Day 1: Regulatory Foundations & Method Validation (5 hrs)Session 1: Regulatory Framework & Compendial Standards
- Seminar Objectives, Expectations & Scope
- Overview of Pharmacopoeias & Compendial Standards (USP)
- Compendial Approval Process (Public Standards)
- Drug Approval Process & Regulatory Requirements (FDA)
- Compendial Harmonization Process
- FDA & USP Requirements
- Introduction to Analytical Method Validation
- Typical Validation Parameters:
- Accuracy & Precision
- Specificity
- Linearity & Range
- LOD & LOQ
- Factors to Consider During Validation
- Different Validation Approaches
- Chromatography System Suitability Requirements
- Allowed Adjustments of Chromatographic Parameters
- Day 1 Wrap-Up & Q&A
Session 1: Instrument Qualification & Method Lifecycle
- Analytical Instrument Qualification (DQ, IQ, OQ, PQ)
- Instrument Categories
- Analytical Method Verification
- Analytical Method Transfer
- Investigative Procedure Lifecycle
- Setting Specifications (FDA Rules & ICH Q6A Strategies)
- Key Regulatory Expectations
- Out-of-Specification (OOS)
- Out-of-Trend (OOT)
- How to Handle OOS & OOT Effectively
- Case Studies & Practical Scenarios
- Final Summary, Review & Live Q&A
Speaker
Kelly ThomasWho Should Attend
Contract Laboratories (CRO)- Academia (pharmacy, Pharmaceutical Industry, Pharmaceutical, Chemistry)
- Government (FDA or regulatory authorities)
- Quality Analysis Managers and Personnel
- Controlling Personnel
- Analytical and or Formulation Chemists
- Quality Control Managers and Personnel
- Lab Supervisors and Managers
- Compendial Liaisons
- Senior or Graduate students (chemistry, pharmaceutical, pharmacy)
- Pharmaceutical scientists/Pharmacists working in Industry
