Introduction to Pharmaceutical Auditing Techniques
December 13, 2019
9:00 a.m. – 5:00 p.m.
CAD $585.00 + HST
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
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.
Auditing of contractors, vendors, and suppliers in the Pharmaceutical industry is not only a regulatory requirement but also a critical Quality practice. Companies are outsourcing more and more of their capabilities to outside experts but the importance of establishing the GMP compliance and Quality systems status of these parties has been undervalued. Many companies fail to appreciate that all their contractors, vendors and suppliers are an extension of their own company and must therefore be held to the same standard that’s expected of them. This is accomplished through effective auditing. Effective and consistent auditing assures a company’s network of external contractors and vendors is at the level of quality required. The result is not only compliance with regulations but also reduced rejects, less problems, and fewer complaints. In the end it helps assure only products of the highest quality are provided to the patient. These auditing principles are equally applicable to internal audits. This workshop will introduce students to:
- The basics of auditing
- Audit planning
- Conducting audits
- Effective auditing techniques
- Audit analysis tools
- Writing audit reports
- Audit follow-up and closure
- Examples and exercises will help to reinforce the workshop topics.
Registration Fee Includes
Presentation Materials, Luncheon, Refreshment and Free Parking
Note: Please indicate any special Dietary requirements when registering for the course
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.