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Drug product impurities attract scrutiny during regulatory review and inspection because of their potential impact on patient safety. Pharmaceutical professionals must understand the regulations and how to implement strategies to minimise impurities in drug products.
This training course examines the different types of chemical impurities of concern to regulators in chemical drug products. In addition to ordinary organic degradation products, you will examine mutagenic impurities (including nitrosamines), residual solvents, elemental impurities and extractables/leachables. Once completed you will have the confidence to navigate the EU, US, USP and ICH regulations surrounding drug impurities.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.
This course is aimed at anyone involved in the control, monitoring and reporting of pharmaceutical drug product impurities. These includes: QA Managers and Personnel | Quality Control Scientists | Method Development Scientists | Analytical Chemists |Laboratory Personnel | Regulatory Affairs Professionals | Qualified Persons.
Pre-course
Action Plan
Reinforcement Session
Overview of regulatory guidance
Case study: nitrosamines in valsartan tablets manufactured by Zhejiang Huahai Pharmaceuticals
Identifying new drug degradation products
Chirality and toxicity
Qualifying/justifying limits for new degradation products
Genotoxic impurities – structural alerts and tests for genotoxicity
Toxicology testing in animals – rationale and types of test
Routes of administration and toxicity
Risk assessments
Worked example: elemental impurities risk assessment
Dr. Mark Powell
is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff in technical writing.
In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in areas such as chromatography, dissolution testing, data integrity, method development/validation, analytical instrument qualification, technical writing and auditing.
Mark not only brings a huge amount of knowledge and experience to his workshops but excellent at delivering interactive and engaging courses with multiple examples throughout.
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