Good Manufacturing Practice Advanced

3 Day/s

CPD Hours: 21

Classroom, online, in-house

RSC approved

This 3 day course systematically builds up the knowledge of delegates over three intensive days. It covers the regulations and guidelines associated with GMPs and the expectations of the MHRA and FDA. Topics examined include incoming materials, including control of suppliers of APIs, excipients and packaging materials. Other sessions examine manufacturing, packaging, premises, equipment, engineering activities, quality systems and laboratory practices. The course is highly interactive and also features several real-life case studies.

Classroom courses
Please note, the advertised venue may need to be changed, if the required number of delegates is not met. In this situation, the course will be converted to an Online Virtual course and all delegates notified accordingly. The decision regarding the venue will be made at least 4 weeks before the course is due to run.

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RSC Logo Approved Training High Res (1)
This course is aimed at key personnel working in management, QA, QC, production, engineering and clinical trials, who wish to have a broader and more extensive appreciation of pharmaceutical good manufacturing practices.
The course covers the following topics:

  • Day 1
    • Why do we have GMP.
    • UK legislation and licensing
      • Human and veterinary medicines regulations
      • Relationship to EC directives
    • Pharmaceutical quality system
    • Role of MHRA
    • How to use the orange guide
  • Day 2
    • GMP in the USA
    • Key people and training
    • Control of Incoming materials
    • Overview and principles of ICH Q9
    • Change management
    • Premises and equipment
    • Pharmaceutical supply chain
    • GMP audit points in production
    • GMP audit points in packaging
    • Deviations and investigations
  • Day 3
    • GMP, QC and GQCLP
    • Calculations, results and OOS
    • GMP and documentation
    • Validation and qualification
    • Auditing and self-inspections
    • Contracting out
    • Complaints and recall

    By the end of the course you will:

    • Be able to find your way confidently around the rules and guidelines of GMP
    • Be able to find your way confidently around the UK ‘Orange Guide’, (which incorporates the EU Guide to GMP)
    • Be able to find your way confidently around the FDA Code of Federal Regulations
    • Have acquired a broad but comprehensive knowledge of GMP allowing you to speak and act with confidence in your work environment
    • Have developed an understanding of the current GMP expectations and how to interpret and apply them in practical situations
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Bring this course in-house

Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Peter Deegan

Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience.

Rob Hughes

Rob Hughes has over 30 years in the pharmaceutical industry spanning various operational, project and senior strategic leadership positions in commercial manufacturing and development QA. Rob, a practising QP, has experience of the application of QA in many different areas including control laboratories, API, solids, creams and liquids manufacture, and third party audit and evaluation. Rob has many years experience of MHRA and FDA inspections.

Sue Mann

Sue has run her own consultancy since 2009 and works with companies all around the world. She became a QP in the mid 1980’s and a QP Assessor in the early 2000’s. Although her core knowledge and experience is in GMP, she has built up knowledge and experience in Good Distribution Practice (GDP) and has helped write a guidance document published by PQG and ECA which expands upon the EU GDP Guideline. Sue has dealt with many GMP systems in her over 40 years’ experience in the industry; including WHO whilst involved in a development project in a number of African countries, funded by UNIDO. Sue has been a QP for many years and understands the complexity of the role and its position within a company. She is an inspiring trainer being able to break down complex topics into understandable sections and can “train” at all levels in an organisation. She understands what it is that is important in fulfilling the role of a QP.

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