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Keeping your analytical method in compliance with Good Manufacturing Practices (GMPs): Validation, Verification and Transfer

October 5

One Day Interactive presentation, case studies and exercises:

Analytical laboratories play important roles in the pharmaceutical industry. The generation of data under conditions that ensure its reliability and allow for post-analysis verification of its authenticity is critical to the drug development process; therefore, keeping the analytical method in compliance with validation requirements and product changes is a challenge for analytical scientists.

This course will review the current regulations, provide updates from FDA, ICH, USP, and WHO, and different aspects of validation throughout development phases to establish critical acceptance criteria. It will also discuss different strategies to transfer an analytical method systematically. Participants should expect to share their experiences and discuss Best Practices to keep method stay in compliance with Good Manufacturing Practices (GMPs).

Friday October 5, 2018 | Time: 9AM-5PM 

Regulatory expectations of Method Validation

    • Current review of critical GMP issues in analytical labs
    • Common 483s observations and warning letters
    • Review ICH Q2 A&B guidelines
    • USP <1225> and <1226> requirements

Development of stability indicating test methods

    • Discuss validation characteristics
    • Stress testing and forced degradation studies
    • Key issues with Q3 A/B for impurities monitoring
    • Validation process and method Lifecycle

Documentation of Method Validation

    • Structure of a validation protocol
    • Establish documentation principles
    • Establish acceptance criteria
    • Content of the Analytical Method

Method Transfer Process

    • Purpose of Analytical Method Transfer
    • USP <1224> and transfer strategies
    • Phases of Method Transfer Process
    • Understand the dynamic relationship of validation, verification and transfer

Interactive discussions on Method Transfer issues




Kim Huynh-Ba, Executive Director, Pharmalytik

Kim Huynh-Ba has 28 years of experience in quality management system, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik (www.pharmalytik.com). Since 2003, she has provided consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching quality audit, Good Manufacturing Practices, ICH regulations, and pharmaceutical analysis.

Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. Kim is a member of the USP Council of Expert chairing the Chemical Medicines IV Expert Committee (2015-2020). She is also the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP Impurities of Drug Products Expert Panel (2012-present). She is also a member of the PQRI Stability Shelf-life working group.

Kim has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets (2010).

This course will benefit analytical chemists, staff scientists, investigators in quality control lab, R&D, production, manufacturing, contract labs, quality assurance, regulatory affairs, laboratory auditors, lab inspectors, data reviewers, lab investigators.
This course is not intended for microbiologists.

Registration Fee & Discounts

Early Bird: Till September 16, 2018

Regular Price: September 17, 2018 to October 05, 2018

$484 CAD + HST $584 CAD + HST

Academia / Government

At all time (Save Over $200.00)

$294 CAD + HST

The fee is payable in advance and includes continental breakfast, lunch & refreshments, course material and certificate of attendance.

Group Registration Discount
Group Registration is available for all our live events. Please contact us: By email: enquiry@ipacanada.com or Call: 416-410-7402

Cancellation Policy
Cancellations received in writing more than 3 weeks before the event will be subject to a service charge of $150.00 CAD. The full conference fees remain payable if cancellations are received less than 3 weeks prior to the event. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organizer to alter the timing of the program or the identity of the speakers. In the unfortunate event that an event is cancelled IPA are not liable for any costs incurred by delegates in connection with their attendance.

Course Venue & Hotel Accommodation

Sheraton Montreal Airport Hotel

555 Boulevard McMillan
Montreal, Quebec
H9P 1B7 Canada
Tel: 514 631 2411
Website: http://www.sheratonmontrealairport.com/

Guests are responsible for their own accommodations. IPA has arranged a special room rate of $149 + taxes for attendees at the Sheraton Montreal Airport (Course Venue). To reserve a room at the Sheraton with our group rate, please call the hotel: 514 631 2411 and mentioned group code: IPA





October 5
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Montreal, Canada


(416) 410 7402