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QC Compliance Trends 2016

8 November 2016

Objectives

It is the aim of this course to address all those GMP Compliance issues that are currently discussed as hot topics in analytical quality control laboratories and during GMP-/FDA-Inspections. This course will give an update about the actual regulatory requirements (EU, US, WHO, etc.) and will show how these requirements can be put into practice. In addition this course will look at scientific and regulatory trends to be expected in the future.

Highlights

  • New EU GMP Requirements of Chapter 5 and 6 for the Analytical Lab from an GMP Inspectors perspective
  • Strategies for Reduced Sampling and Reduced Testing
  • New challenging ANVISA (Brazil) requirements about validation of analytical procedures and expectations of the Brazilian authorities
  • Analytical Validation in pharmaceutical analysis including the lifecycle approach to analytical validation
  • Elemental Impurities - current status and requirements and impact of new guidelines (ICH; USP; Ph.Eur.) on drug products and out of scope products
  • The Chinese GMP and Pharmacopeia: How to comply?

Speakers

  • Dr Gabriele Wanninger, Head of the Department Pharmacy, inspectorate Southern Bavaria, Government of Upper Bavaria, München, Germany
  • Samantha Butler, Teva Pharmaceuticals Ireland, Ireland
  • Magdalena Novak, Cambrex Karlskoga, Karlskoga Sweden
  • Ulla Bondegaard, Novo Nordisk, Bagsværd, Denmark
  • Dr Gerold Schwarz, Analytik Jena AG, Jena

 

Biosimilars - Case Studies and Practical Advice

 

PDF of the Conference QC Compliance Trends 2016
9 November 2016

Please also see the complete agenda.