Fundamentals of Formulation and Manufacturing Workshop

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Dates Available

February 22, 2019

Time

9:00 a.m. – 5:00 p.m.

Cost

CAD $585.00 + HST

Location

AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

Distinguished Faculty

Andy Tallevi Formulation/Process Consultant
Keller Consulting

Andy Tallevi is a Formulation/Process Consultant for Keller Consulting in Mississauga, Ont., Canada. He has 28 years of industrial experience, primarily in the Pharmaceutical industry. He currently consults clients in the Pharma and chemical industries assisting them with formulation and process issues and is an instructor at AAPS.

Most recently Andy spent 1 year with Health Canada in the Bureau of Pharmaceutical Sciences reviewing and evaluating generic submissions and making recommendations for approval or refusal of Notice of Compliance for the Bureau. He has gained significant insights to the regulatory requirements and expectations of the drug substance and drug product sections of a submission filing to Health Canada. In addition, he has an excellent understanding of the regulatory requirements for pharmaceutical development, the GMP requirements expected for pharmaceutical manufacture and has assisted former employers numerous times in audits by Health Canada and the FDA.

Prior to this, Andy worked as a Senior Pharmaceutics Scientist for GlaxoSmithKline in Canada. During his 18 years with the company he led many projects developing new chemical entities in varying dosage forms. His specialty is solid oral dosage forms. He and his team successfully formulated immediate release tablets as well as many controlled release versions of GSK new chemical entities. He has experience with conventional matrix approaches as well as proprietary technologies such as Procise® and DiffCORE®. He has been responsible for overseeing the manufacture of clinical supplies of NCEs both in Canada and at other GSK sites in Europe and the US.

Andy also has a solid understanding of material properties required of excipients and actives for successful formulation and for robust processes. He is well versed on particle sizing and powder flow. He holds a US patent on a novel approach for the assessment of the flow of pharmaceutical powders.

Prior to leaving GSK he was heavily involved in a company-wide effort to strengthen its processes by Design for Manufacture through the use of PAT and experimental design for which he was the lead user in Mississauga.

Prior to GlaxoSmithKline Andy worked as a scientist for Unilever developing products in the health, beauty and detergent industries. He graduated from the University of Toronto with a B.Sc. major in Chemistry.

Andy lives in Mississauga with his wife and 2 children.

Abstract

Pharmaceutical drug products come in a variety of dosage forms and comprise of distinct formulations manufactured according to specific processing instructions. Formulation scientists develop pharmaceutical products in conjunction with specialists in other disciplines such as pharmacokinetics, pharmacology, toxicologists, clinicians and others to ensure the final product is safe, effective and of the highest quality.

This introductory course will provide an overall understanding of how an API is formulated into a drug product, how the physical properties of the API are critical to the development effort, and how the manufacturing process is strictly dictated by the nature of the formulation. A high level review of the formulation requirements, manufacturing unit operations and manufacturing equipment requirements of several common dosage forms will also be presented.

In particular, the following topics will be covered:

  • Introduction to pharmaceutical formulation and manufacturing
  • API properties that influence formulation
  • Common excipients used to formulate drug products
  • Basics of formulating a drug product
  • Immediate release
  • Controlled release
  • Formulating tablets
  • Manufacturing tablets
  • Formulating liquids
  • Manufacturing liquids
  • Formulating semi-solids
  • Manufacturing semi-solids
  • Overview of some specialty dosage forms

The course is designed for those who work in Quality, Regulatory Affairs, Clinical Research, etc. and wish to gain a more in depth knowledge of pharmaceutical formulation and manufacturing.

Registration Fee Includes

Presentation Materials, Luncheon, Refreshment and Free Parking (Please indicate any special Dietary requirements when registering for the course)

Note: Registration closes one week prior to the start of workshop.

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.