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.

Course Overview

For many years pharmaceutical companies have placed considerable effort in developing robust manufacturing processes to assure the highest quality products, minimize defects, eliminate rejects and conform to all Regulatory requirements. These processes are developed by scientists using past knowledge and 1 variable-at-a-time experiments and then subjected to process validation. Unfortunately, more often than not, even validated processes fail.

At the core of this problem is the fact that full process knowledge has not been acquired and all critical factors have not been identified. This implies that the manufacturing process can drift into a region not fully explored and produce an output that falls outside acceptable limits.

For the past decade and more the pharmaceutical industry, supported by Regulators, has been looking to Quality by Design (QbD) to remedy this problem. In pharmaceutical manufacturing the concept is to carry out experimentation and analysis using multivariate statistical techniques to determine all the factors influencing the process (critical factors), determining the complete region around those factors that produce a given output (design space) and then determining the optimal portion of the design space that produces the desired output within limits (optimization).

In this webinar participants will learn about:

• Basic concepts of Quality by Design (QbD)
• Advantages of QbD over traditional 1 variable-at-a-time experimentation
• Statistical experimental design
• Critical factors
• Factor interactions
• Design space
• Interpretation of data derived from QbD
• A real life example of QbD applied to a pharmaceutical granulation process to fully understand the critical factors and the optimal operating range within the design space for those factors

Note: Course outline is subject to change without notice. Please check back regularly for updates.

Who Should Attend

The webinar is suitable for those who are seeking to get a basic understanding of the concept of Quality by Design and its application to pharmaceutical processing including personnel in Production, Quality Assurance, Quality Control, Validation and Development.