Recorded Webinar – Accelerated HPLC testing in a GMP lab

Distinguished Faculty

Dwight Bryan has over 20 years’ of experience in the Pharmaceutical and Medical Device Industries. He has held roles of increasing responsibility in Finance, Sales, Learning & Development, Sales Management and Continuous Improvement at Eli Lilly Canada. He has also held lead roles in the deployment of Lean transformations at Cardinal Health, Novo Nordisk and AstraZeneca. He now leverages his expertise as a Lean consultant to the pharmaceutical industry and other healthcare related organizations.

Dwight obtained his B.Sc. in Mathematics and Computer Science from the University of the West Indies, and subsequently completed his MBA in Finance at the Schulich School of Business. He is also a certified Lean Six Sigma Black Belt. For over a decade Dwight has utilized his process improvement skills to address complex business processes which impact quality and customer satisfaction. He has led cross-functional initiatives that have impacted Quality Assurance, Regulatory Affairs and Supply Chain among other areas.

Some projects he has undertaken include improving the Quality Management Review Process, streamlining and enhancing compliance for the distribution of cold chain pharmaceutical samples and eliminating delays in product transitions. Dwight has also led cultural transformations by engaging staff in Lean, including training scores of individuals and certifying them at various levels of Lean proficiency.

Abstract:

The implementation of Good Manufacturing Practices (GMPs) is crucial for maintaining product quality and compliance in regulated industries such as Pharmaceuticals, Cosmetics, and Food. High Performance Liquid Chromatography (HPLC) plays a pivotal role in analytical testing for these industries since it offers high sensitivity, selectivity, accuracy, and reproducibility in the quantitation of analytes.

This half-day webinar delves into the advantages and details of employing HPLC in GMP-compliant analytical testing, including the ability to separate complex mixtures and detect/quantitate active pharmaceutical ingredients and trace impurities with unparalleled precision. Examples of typical HPLC analytical methods and GMP documentation will be provided and discussed. By the end of this course, you will know how to perform GMP analytical testing by HPLC to ensure the safety, identity, strength, purity, and quality of pharmaceutical, cosmetic, and food products in today’s highly regulated and dynamic industry.

Course Outline:

• HPLC basics
• Parts of an HPLC
• System Suitability and good practices
• Mobile phase, HPLC columns, standard/sample preparation
• GMP documentation of HPLC testing
• Empower 3 software overview
• Common HPLC tests – Identification, Assay, Content Uniformity, Impurities
• Peak integration

Who Should Attend

This is a “refresher” half-day webinar intended for an audience with no, or intermediate, knowledge of GMP analytical testing using HPLC. It is valuable for staff in the Pharmaceutical, Cosmetic, Food, or related industries. This includes, but is not limited to, the following departments:

• Quality Control Laboratory
• Analytical Research and Development Laboratory
• Quality Assurance

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 Certificate of Attendance and Course Material

• All participants will receive a certificate of attendance upon completion of the course.
• The participants will be receiving specially prepared course manual.

Registration Fee Includes

Presentation Materials, Luncheon, Refreshment and Free Parking Note: Please indicate any special Dietary requirements when registering for the course–>