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Live Online Conference: Challenges in Bioanalytical and Analytical Laboratories - Day 2 - Analytics - From Life Cycle Management to Real Time

11 November 2020

Objectives

It is the aim of this Live Online Conference is 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 Live Online Conference 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.

Topics that will be addressed are:

  • Analytical Procedure Lifecycle Management
  • Handling OOS/OOE/OOT
  • Real-time measurements of starting materials used in tablet production
  • Strategic design of HCP analysis during clinical phases
  • Pharmacopoeial Challenges
  • Key figures in pharmaceutical quality control laboratories

Target Audience

This Live Online 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 Live Online Conference is also intended for employees working in contract labs being involved in development of methods, control testing and Quality Assurance. It is also useful for service providers, such as contract research organisations and contract manufacturers,

Programme

Congress Keynote 11.11.2020: RTRT: A Reality Check in the Small and Large Molecule World

09.00 - 09.45 h
Key Note: RTRT: A Reality Check in the Small and Large Molecule World
Dr Lorenz Liesum, F. Hoffmann-La Roche

09.45 – 10.30 h - Analytical Procedure Lifecycle Management, practical Implementation of Routine for Process Verification
Ulla Bondegaard, Novo Nordisk

10.30 – 11.00 h - Life Cycle Management of Analytical Procedures - Regulatory Perspective
Ketan Agravat, rK3 Solutions

11.00 – 11.15 h Break

11.15 – 11.45 h - Key Performance Indicators in Pharmaceutical Quality Control Laboratories - Tools to measure and monitor Optimizations
Dr Karl-Heinz Bauer, Boehringer Ingelheim

11.45– 12.15 h - The value of Pharmacopeial RS: A Story about Uncertainties, associated Guard Bands and Secondary RS
Dr Christian Zeine, USP

12.15 – 12.45 h - Questions and Answers

12.45 – 13.45 h Break

13.45 – 14.15 h - Small Molecule Drugs & Analytics - SWOT Analysis on the OOS/OOT/OOE established System
Laura-Felicia Cristescu, STADA Hemofarm SRL (STADA Group )

14.15 – 14.45 h - Validation of Analytical Methods 
Judith Kernbichler, Takeda

14.45 – 15.15 h - OOS, OOT, OOE – Update from practical Experiences
Dr Jörg Neumann, Jörg Neumann Beratung

15.15 – 15.30 h Break

15.30 – 15.45 h - Strategic Design of HCP Analysis during Clinical Phases
Kai Kottwitz, Rentschler

15.45 – 16.15 h - Real-time Measurements of Starting Materials used in Tablet Production
Roland Koch, Gasporox

16.15 – 17.00 h - Questions and Answers

Speakers

Ketan Agravat, rK3 Solutions, India
Chief Executiv Officer.

Dr Karl-Heinz Bauer, Boehringer Ingelheim, Germany
Head of Quality Unit DPI/MDI.

Ulla Bondegaard, Novo Nordisk, Denmark

Laura-Felicia Cristescu,, STADA Hemofarm SRL (STADA Group), Romania
QA and Local Pharmacovigilance Officer Deputy.

Judith Kernbichler, Takeda, Austria
Head of Analytical Sciences Knowledge Management.

Roland Koch, Gasporox AB, Sweden
Senior Application and Sales .

Kai Kottwitz, Rentschler Biopharma, Germany
Quality Control Manager.

Dr Jörg Neumann, Jörg Neumann Beratung, Germany
Founder and CEO.

Dr Christian Zeine, USP
Senior Scientific Affairs Manager EMEA.