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.
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.
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.
Agenda
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.
Virtual Delivery Due to COVID-19 (3/15, 3/22 and 3/29)
Course times are 10:00 AM-12:00 PM and 2:00-5:00 PM (both ET) on each day of the course. Check-in starts at 9:45 on each day. Course fee includes electronic access to the course manual, access to pre-course networking forum, access to discussion forums with the instructor, and a course certificate of completion.
To complete your registration, you will be asked to log in using your ACS ID. If you are not already logged in, you may enter your credentials or create an ID from the next screen.
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.”
