Distinguished Faculty

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.

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Course Outline

I. Regulatory Requirements for GMP Documents

• Analyze GMP requirements for batch records
• Types of Regulated documents and relative importance
  • Master Batch Record
  • Raw Material Records
  • Manufacturing Records
  • Specifications
  • Raw Data
  • Investigations-Deviation and Out of Specifications
  • Change Control (batch scale up/down)
• Development of a Master Batch Record
  • Relationship between R and D, Validation and Production

II. Basic Requirements and Techniques for Batch Record Review

• Review process and SOP
• Roles and responsibilities
• Effective review practices and tools to identify discrepancies
• Application skills for preventative actions

III. Techniques for Performing a Technical Review and Conducting Follow-Up Investigations

• Review of Analytical Data
• Ensure correct reconciliation (product, label)
• Investigation processes (Out-of Specification test results and deviations)
• Production process consistency
• Product disposition evaluation

IV. Workshop – Review of a Mock Batch Production Record

V. Documentation GMP and Regulatory Trends

Who Should Attend

This one day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

• Regulatory Affairs
• Quality Assurance
• Product Submission
• Training
• Consultants
• Clinical Research
• Documentation and Technical Writing
• Project Management
• Product Development
• Others who interact together to launch a product

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.

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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.

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