In-Person Risk-Based Strategy for the Development and Validation of Analytical Methods with a QbD Approach
Learn the fundamentals of quality assurance, quality control, and analytical methods validation and how to improve your FDA, WHO and USP regulatory compliance directives for analytical data submissions.
About the Instructor(s)
Managing Director, Pharmalytik
Kim Huynh-Ba is the Managing Director of Pharmalytik, a consulting and training organization. She has almost 30-yr experience in Quality systems, strategic drug development, and stability sciences. She is a Council of Expert of US Pharmacopeia, where she chairs the Chemical Medicines IV expert committee. She is also a member of the USP Organic Impurities of Drug Products Expert Panel. She is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology, where she teaches Quality Audit, GMPs, ICH quality guidelines, and Pharmaceutical Analysis. She is the editor of the two well-known stability handbooks and is completing a new manuscript entitled “Analytical chemistry: A handbook of Pharmaceutical GMP Laboratories.”
About the Course
Learn the fundamentals of quality assurance, quality control, and analytical methods validation and how to improve your FDA, WHO and USP regulatory compliance directives for analytical data submissions. Areas of concentration include conformity assessment; analytical method optimization during development; case studies in the improvement of validation characteristics; data integrity and statistical evaluation of analytical data; and more.
- Highlights of the guidelines derived from international standards-ICH Q1 (R2), ICH Q2 R1, Q3, USP <1225>, USP <1226>, USP <1224>, GLP, GMP, etc.
- Conformity assessment – what it is, how it is applied.
- Analytical method optimization during development.
- Case studies in the improvement of validation characteristics.
- Method development and optimization in HPLC.
- ICH and USP guidelines for methods validation and other standards.
- Regulatory submission packages for IND, NDA, ANDA and other phases of development.
What You Will Learn
- Increase your knowledge of conformity assessment, quality control, and quality assurance.
- Consult with a knowledgeable instructor about your current technical problems and preparation and requirements for submission of regulatory packages (NDA, ANDA, IND, MMA and others for FDA & USP).
- Become acquainted with practical approaches for validating new analytical procedures.
- Be exposed to the latest international requirements and guidelines: ICH, USP & FDA guidelines for analytical validation.
- Learn about the FDA’s new initiatives in systems-based inspection and risk-based assessment.
- Understand the training and supervision requirements of chemists and technicians and other lab personnel for GXP.
- Receive helpful hints to help prepare you for a visit from an auditor’s perspective.
- Participate in discussions on cGXP and WHO requirements and expectations.
- Learn about general validation and qualification requirements for analytical instruments.
Who Should Attend
Scientists, managers, and technicians involved in methods validation and optimization, analytical research and development, meeting FDA requirements and regulations, validating analytical methods, application of newer analytical methods, and those involved in quality control, quality assurance, and quality assessment.
- Fundamentals – Quality, Quality Control, and Quality Assurance, general discussions on quality, QC, QA, and guidance from domestic and international standards; definitions and descriptions of validation parameters; principles of method validation, conformity assessment and laboratory QA.
- Method Validation – Guidelines Derived from FDA, ICH, USP, examples of development and optimization of methods and development of validation criteria; definition of ruggedness, reproducibility, system suitability, precision, accuracy, LOD, LOQ and other validation parameters for FDA compliance.
- Method Development and Optimization by Example and Case Studies – How to systematically develop and optimize a chromatographic method.
- Change Control of analytical method – Aspects of HPLC that can be optimized, including procedures; peak purity, spectral match, peak tailing and other considerations in HPLC.
- Statistical Treatment of Analytical Data – Mean, Mode, Standard Deviation, Control Charts, etc.
Dates, Locations, and Prices
Five for four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. The free registration will be the course of the lowest price.Please note: This discount cannot be combined with any other discount offered.
Date and Location: TBD