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Management Forum

Understanding Active Pharmaceutical Ingredients (APIs) Training Course

A comprehensive and practical introduction

This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

17-18 July 2024
+ 18-19 November 2024 »

from £1099

Need help?  Enrol or reserve

Overview

An active pharmaceutical ingredient (API) or drug substance is any substance or mixture of substances intended to be used in the manufacture of a medicinal product, which is intended to furnish pharmacological activity, or have another direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or affect the structure and function of the body. 

This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry.  It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.  Practical exercises will form part of the course to aid the learning process.

This is an essential and valuable introduction to the manufacture of APIs.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of Attending

  • Gain a comprehensive overview of the API regulatory framework
  • Enhance your understanding of the key terms used in API manufacture
  • Recognise how Good Manufacturing Practices (GMP) apply to API synthesis
  • Understand the different approaches between small molecule and large molecule processing
  • Learn how to manage the risk associated with your supply chain

 

Who Should Attend

  • New entrants to those individuals working in a GxP environment
  • Quality management manufacturing specialists
  • Regulatory compliance specialists
  • Pharmaceutical technical professionals
  • Pharmaceutical professionals looking to enhance their Continuous Professional Development (CPD)

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The Understanding Active Pharmaceutical Ingredients (APIs) course will cover:

Introduction to APIs

  • Terminology and acronyms
  • Globalisation
  • Introduction to the regulatory framework

Methods and equipment - Part 1

  • Chemical synthesis
  • Reactors
  • Isolation
  • Drying
  • Exercise: managing particle size

Methods and equipment - Part 2

  • Biological
  • Fermentation
  • Harvesting
  • Exercise: impurities

Good Manufacturing Practice (GMP)

  • Requirements
  • Regulations
  • EU
  • FDA
  • Exercise: similarities and differences

GMP requirements (continued)

  • Pharmaceutical Quality System
  • Validation and Qualification
  • Outsourcing
  • Exercise: specialist or generalist

Supply chain considerations

  • Falsified Medicines Directive (FMD)
  • Good Distribution Practice (GDP) for APIs
  • Exercise risk mitigation

Introduction and recap of Day 1

Registration aspects of production and control

  • The registration process
  • The Common Technical Document (CTD)
  • Active substance/drug master files
  • Exercise: strategy

Laboratory controls

  • Good Quality Control Laboratory Practice (GQCLP)
  • Validation
  • Stability
  • Exercise: data Integrity

Process validation

  • Purpose of validation
  • General considerations
  • Exercise: critical attributes

Cleaning validation

  • Cleaning strategy
  • Key requirements
  • Residues
  • Exercise: purpose

API control packaging materials

  • What to consider
  • Data requirements
  • Extraction, interaction, migration and sorption
  • Toxicology
  • Exercise: environmental factors

Wrap up and Q & A

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Paul Palmer
Paul R Palmer Ltd

Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices. 

Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.

People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.

Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.

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Farah Nadeem
Paul R. Palmer Limited

Farah Nadeem is an Operations Manager at Paul R. Palmer Limited/ Pharmaceutical Consultant and a Trainee Qualified Person. Farah is a Pharmacist and recognised QA expert and has over 20 years of experience in the Pharmaceutical industry in the development, manufacture and supply of medicinal products.

Throughout her career, she has held various quality assurance roles and actively pursued new opportunities to expand her knowledge and expertise. As a result, she has gained a comprehensive understanding of manufacturing, storage, and distribution processes, as well as the facilities and services that support them. Involved in documentation management: writes, reviews, and audits SOPs and QMS implementations. Assists companies in meeting regulatory requirements.

In her current role as a QA Operations Manager for a Pharmaceutical Consultant Company, Farah Nadeem provides various solutions, including assistance in obtaining the first MIA(IMP) and MIA licenses, as well as preparation and hosting for regulatory inspections. Her work involves collaborating with Paul Palmer to offer services such as QP declarations for API manufacturers, regulatory inspection hosting, commercial and clinical batch release, compliance audits, and coaching and training in GxP.

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NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

17-18 July 2024

Live online

09:30-17:30 UK (London) (UTC+01)
10:30-18:30 Paris (UTC+02)
04:30-12:30 New York (UTC-04)
Course code 13834

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 12 Jun

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Not ready to book yet?

for 7 days, no obligation

18-19 November 2024

Live online

09:30-17:30 UK (London) (UTC+00)
10:30-18:30 Paris (UTC+01)
04:30-12:30 New York (UTC-05)
Course code 14052

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 14 Oct

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

United Kingdom

  • MHRA
  • Theramex

Germany

  • NAGASE (EUROPA) GmbH

Netherlands

  • Biosynth B.V.

Poland

  • Theramex HQ UK Limited

Slovak Republic

  • Ewopharma International s.r.o

United States of America

  • BioMarin

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy