Mastering Impurities in Pharmaceuticals - EU Version

18-19 November, 2024

Purpose of process validation and its 3 stages

ONLINE TRAINING | 18-19 November, 2024

Starting time: GMT 09:00 a.m.

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Key Takeaways

Detailed insights regarding the current guidelines

Current developments

Different approaches for establishment of control strategies

Awareness for risk assessments

masterclass in pharma

Overview

Impurities in active ingredients, excipients, medicinal products and packaging materials are important attributes in the assessment of quality and safety of medicinal products - this applies to all phases of the product life cycle. Not least the contamination by nitrosamines has changed regulators view of the subject and today we have to deal with the subject more intensively. Impurities are on the move, applicants and marketing authorization holders need to anticipate potential impurities and to subsequently identify, specify and qualify respective compounds. This applies to projects with new products, but also to specific occasions, such as the renewal of marketing authorisations, the sourcing of new active substances and excipients, changes in production and site transfers.

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MEET THE TRAINER

DR. RALPH NUSSBAUM

Head of Quality
Omega Pharma

Dr.Nussbaum worked at Gruenenthal GmbH from 1995 to 2000 as Head of LaboratoryR&D Analytics before moving to CarboGen Laboratories AG in Hunzenschwil, Switzerland, as Head of Quality Control and later as the person responsible for
drug substances. From the end of 2003 to July 2017, he was Head of AnalyticalServices in Aachen, now SYNLAB Analytics & Services Germany GmbH. From October 2017, he was responsible for the entire pharmaceutical division of SYNLAB as Division Manager. In August 2020 he joined Auregen BioTherapeuticsGmbH as Vice President Quality Management. Since August 2024 Dr. Nussbaum is Head of Quality and Qualified Person at Omega Pharma Manufacturing GmbH & Co KG in Herrenberg, Germany

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Reasons to attend a masterclass

Practical knowledge

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Interactivity

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World-class trainers

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Networking

Build a top-notch community and advance your career

Who should attend?

-People in charge for development of synthesis and control strategy for APIs
-People in charge for pharmaceutical development and control of medicinal products
-Regulatory Affairs Personnel
-Heads of quality control
-EU Qualified Persons