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Juin
2018

Active Pharmaceutical Ingredients - QP Module

Royaume-Uni, Newcastle upon Tyne

25 juin 2018 - 29 juin 2018

Entrée : 2 880,00 £ (HTVA)

Déjeuner: inclus
Multiple delegate discounts available. Discounts also offered to NHS staff, regulators and charities.
Public ciblé: Aspiring Qualified Person Pharmaceutical Technical Professional
Ajouter

Course overview :

This course gives a unique insight into the regulatory expectations associated with producing both chemically synthesized APIs and biological/biotech APIs. Delegates will practice interpretation of the key API regulations and see them in operation during visits to two API manufacturing facilities. This course fulfils the requirements of the Qualified Person Study Guide and we don’t just train to pass a viva, we take the time to prepare you for your career ahead. The course also provides insight and expertise on managing global API supply chains, vendor quality assurance and “how to audit” API facilities.
 

Benefits :

As API supply chains become ever more diverse and cost pressures more acute, the pharma manager needs a keen appreciation of risk factors, design, control and monitoring of API sources. This course allows delegates to differentiate between natural variation and risk across a range of API processes, indicating the most appropriate and proportionate actions to take to mitigate any areas of concern.

It provides practical guidance on the key responsibilities of the Qualified Person when approving a GMP declaration, how to meet 2004/27/ EC, how to manage change of API source, how to audit and how to provide oversight of remote or contract manufacturing capabilities.

Remember too, our detailed educational material grows into a lifelong reference library.


Course content :

For both chemically and biologically produced APIs, the course includes : 

  • Common process steps and their effect on the quality of the final drug substance
  • EU and US regulatory requirements
  • Comparison and contrast of API facilities
  • How GMP is implemented across the key production processes
  • Common sources of GMP non-conformance and adulteration or misbranding
  • Vendor assurance, management of supply chains and auditing of facilities by QA or QPs – scope, execution and follow-up of audits
  • Visits to state of the art facilities and discussions with on-site pharma professionals

A Unique Opportunity to Visit API Manufacturing Sites: The course will include visits to local state-of-the-art API manufacturing facilities putting into practical perspective the key issues discussed in the lectures.

This course is now four and a half days in duration and includes detailed guidance on “how to audit API facilities”. This course is also RSC Approved.



Registration link :

  • NSF Online registration : Link

NSF contact :

Note : 

  • All of our courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Active Pharmaceutical Ingredients

  • The Regulations
    • EU and US regulations and guidelines
    • Drug Master Files and Certificates of Suitability
    • Key GMP guidance – ICH Q7
  • Manufacturing Processes and Quality
    • Key issues for…
      • Synthesis
      • Purification and impurity control
      • Packaging
    • Process Validation
  • Supply Issues for the Dosage Form Manufacturer
    • Supplier selection and audit
    • Supply chain integrity
    • Technical Agreements
    • Certificates of Analysis


Bulk Biologicals and Biotech Products

  • What is a Biological or Biotech Product?
  • EU and US Regulatory Aspects
  • Essential Characteristics of Biologicals
    • Antibiotics
    • Vaccines
    • Blood products
    • Monoclonal antibodies
  • Quality Aspects
    • Control of starting materials
    • Control of cultivation, harvest and purification
    • Analytical and bioassay techniques

Excipients

  • Regulatory Environment
  • GMP Guidances/Codes
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    John Johnson

    QP since 1995 and a QP Assessor since 2005

    28 years’ experience in the pharmaceutical and healthcare industry

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    Roger Guest

    Consultant

    Registered pharmacist

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    Peter Monger

    Chemist / Fellow of the Royal Society of Chemistry

    40 years of experience in the pharmaceutical industry

Suivant

Résumé

Executive Director at NSF, John has vast experience in preparing sites for regulatory GMP inspections, preparing or remodelling biopharma and steriles facilities, installing quality systems and helping companies embed the right culture for long term sustainable growth. A passionate educator, John has a track record of improving service, improving margin and ensuring perpetual GMP inspection readiness.

Roger has held senior roles within R&D, Manufacturing and QA with several blue-chip pharma and biotech companies. He has been responsible for the design and implementation of new sterile manufacturing facilities and has extensive experience of the development of IMPs and biologicals from formulation to manufacture.

Peter has extensive international experience across APIs and all pharma dosage forms in fields as diverse as auditing, consultancy and specialist training. He brings a unique insight from his service within the MHRA inspectorate, and has a pragmatic yet deep understanding of cGMP.

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