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Challenges in Analytical QC

11 November 2020

PharmaLab-Kongress 2020 - Call for Papers

Become part of the PharmaLab Congress 2020 – as a Speaker

Please complete our online form. The deadline for submissions is 15 April 2020.

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.

Background

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. Many laboratory-specific citations can be found after inspections of European GMP supervisory authorities in EU Non GMP Compliance Reports or after FDA inspections in 483s and Warning Letters. Currently the status of FDA inspections and the impact for analytical labs is of great importance. Discuss with us the future of FDA-inspections in the light of the MRA and get some understanding what this means for your QC-labs.

Furthermore the uncertainty about the consequences of the Brexit for the pharmaceutical industry is a huge challenge for all QC Mangers and QPs. Get some insights what this means for manufacture, testing and release as of 30. March 2019 and how to get prepared for this changes.

Possible topics that will be addressed are:

  • Guidelines developed by the ECA QC Group
    • OOS
    • OOE/OOT
    • Data Governance (with the DI & IT Compliance Group)
    • Analytical Procedures Lifecycle Management (QbD for Analytical Methods)
  • Hot topics in GMP Compliance Inspections in Analytical Labs from an European GMP Inspector
  • Cleaning Validation for Analytical Equipment – what are the regulatory expectations today and how to implement in your lab?
  • cGMP Compliance Trends
  • Defining and Managing Raw Data
  • Current Trends and Future of FDA Inspections (MRA)
  • Training in QC

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 working in contract labs being involved in development of methods, control testing and Quality Assurance.