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Pharmaceutical Drug Product Impurities
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Pharmaceutical Drug Product Impurities

Register Your Interest

This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

Register Your Interest

 

Register your interest in the course. When we schedule dates, we will be in touch.

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

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.

Key Learning Objectives

  • Learn about the regulatory background and recommendations for the control of impurities in drug products
  • Appreciate the different types of impurities and when/how to control them
  • Understand current and future industry trends, including the forthcoming ICH guidance on extractables and leachables (ICH Q3E)
  • Learn how to apply the principles of quality risk management to the control of different impurity types
  • Understand the importance of vendor documentation and how to use it
  • Be able to justify and document decisions regarding impurity control strategies
  • Be able to define and demonstrate FDA, EU, USP and ICH compliance to regulatory agencies

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer.
  • Interactive and engaging sessions with exercises and discussions.
  • Bitesize learning.
  • Access to the Educo Life Sciences Training Portal.
  • Unlimited access to the recordings for 4 to 5 weeks after the last session.
  • A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.
  • A validated certificate of attendance is available for you to download.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

Dates TBC

1 Week Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Day 1

Overview of regulatory guidance

  • Control of ordinary and mutagenic organic impurities (ICH Q and M guidance’s)
  • Distinction between synthetic impurities and degradation products
  • Safety of impurities (ICH S guidance’s)
  • Residual solvents and elemental impurities
  • Extractables and leachables

 

Case study: nitrosamines in valsartan tablets manufactured by Zhejiang Huahai Pharmaceuticals

 

Identifying new drug degradation products

  • Early information: retention time and UV spectrum
  • LC-MS: ionisation and mass analyser types vs. information quality
  • NMR
  • IR
  • Concentration by fraction collection or selective extraction
  • Confirmation of identity/toxicity by synthesis
  • Drug product stress studies to confirm mechanism of formation

 

Chirality and toxicity

 

Day 2

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

  • New degradation products
  • Nitrosamines
  • Elemental impurities
  • Residual solvents

 

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.

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.

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