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QC Compliance Trends in Analytical Laboratories

21 November 2018


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.


Due to changing regulatory requirements pharmaceutical quality control units are continuously facing new challenges. There are many regulatory requirements relevant for the pharmaceutical quality control, both in EU and in the US, for instance EU GMP Guide, 21 CFR Part 210/211 (USA), EMA and FDA Guidances, WHO Recommendations and Pharmacopoeias (Ph.Eur., USP, JP).

Laboratory Managers and Analytical Scientists must be familiar with all these GMP-related topics and must be aware of the latest updates and the current interpretation of all these guidance documents.

In addition, analytical QC laboratories are increasingly in the focus of GMP inspections, both in Europe and in the US. For instance after FDA inspections, many laboratory-specific citations can be found in 483s and Warning Letters. And many findings related to the laboratory can also be found after inspections of European GMP supervisory authorities.

Potentially interested topics could be (Case studies about the practical implementation preferred)

  • EU GMP Requirements of Chapter 5 and 6 for the Analytical Lab – Practical examples of current interpretation
  • Hot topics in GMP Compliance Inspections in Analytical Labs (EU / U.S.)
  • Case Study: Successful lab documentation
  • Practical implementation of USP <1058>
  • Handling of OOE and OOT Results – how to realize in practice?
  • Cleaning Validation for Analytical Equipment – what are the regulatory expectations today?
  • Future USP Expectation: Lifecycle Management for Analytical Methods (Including Impact on Changes/Variations)
  • QbD for Analytical Methods - Challenges and Benefits
  • Knowledge Management in the laboratory - systems to ensure that “everyone knows everything”
  • Excipients and raw materials: how to confirm compliance with pharmacopoeias

Target Audience

This conference will be of significant value to

  • Laboratory managers
  • Quality control managers
  • Qualified Persons (QPs)
  • Analytical scientists
  • Senior laboratory staff

from quality control units in the pharmaceutical industry (routine QC and in research and development) who are responsible for GMP Compliance in the analytical laboratory. This course is also intended for employees in Quality Assurance and from contract labs.