Course Overview

  • “Very intelligent, very informative, very inspirational!” Jeroen Coenen / MSD Animal Health, UK
  • “You do a great job at building an understanding of the topics rather than just listing details and citing guidelines. Thank you.” Georg Beiske / Bayer, Germany
  • “Excellent overview of production of biotech products!”Sandra Grote / Beverborg, Organon, The Netherlands
  • “Enjoyed the opportunity to learn from highly knowledgeable tutors.” Michael Edwards / GlaxoSmithKline, UK

The development and manufacture of biopharma products is set to be one of the fastest growing sections of the industry. Advances in technology commonly outstrip the regulations as new innovative therapies or production processes become available. Making sure your company balances world class science with risk-based approaches to GMP compliance is critical to staying within the regulator’s expectations of the cGMPs.

About This Course

Are you aware of the emerging importance of innovative biopharmaceuticals in the world healthcare market?

Growth often outstrips regulation, so learn how a bioprocessing unit remains in step with a rapidly transforming set of regulatory expectations, make certain your quality system evolves and ensure perpetual GMP inspection readiness for your facility.

Regulatory action and discontinuation of supply can cause catastrophic revenue losses in this high risk sector, so how can you assure supply, reduce GMP risks, reduce product losses and improve yields? This course shows how – using case studies, team-based exercises and discussion of common causes for concern.
Delegates will gain insight into the identification, interpretation and mitigation of risk across a typical bioprocessing train, ensuring that proportionate oversight is applied to the areas of highest risk.

Using illustrations of how the regulatory expectations are interpreted in practice, delegates will be able to critique and modify their quality system to suit the biotech sector. Also delegates will sharpen their skills on ‘how to audit’ bioprocessing facilities, manage contracted out processes and tackle common GMP non-conformances.

If companies are to be successful in this highly important arena, it is essential that staff at all levels clearly understand:

  • The risks and challenges associated with biopharmaceuticals manufacture and control
  • The rapidly changing international regulatory demands and expectations for these products
  • How these requirements can be translated into a practical, effective and cost-effective PQS
     

Key Learning Objectives

On completion of this course delegates will know and understand:

  • Current EU and US regulations and expectations for the manufacture of biopharmaceuticals for commercial and clinical trial use
  • Key GMP compliance issues for the different stages of the manufacturing process
  • How to control seed banks, cultivation, harvest, downstream processing and purification methods
  • The design of biopharma facilities
  • QC strategies and key differences compared to characterisation of small molecules
  • Shipping and cold chain management
  • Key issues of importance to the Qualified Person
  • How to design and execute effective cGMP inspections of biotech facilities

Course Outline

  • Regulatory Issues
    • US and EU regulatory frameworks for biopharmaceuticals
    • Current GMP regulations, guidelines and ‘hot topics’
  • Premises and Plant
    • Fundamental design concepts and segregation
    • Specific requirements for multiproduct facilities
    • Environmental classification and monitoring
  • Starting Materials
    • Sampling and testing requirements
    • Supplier certification
    • GMP requirements for cell banks/seed lots
  • Specific GMP and Validation Requirements for
    • Cultivation and harvest
    • Purification
    • Virus and DNA clearance
    • Cleaning and cleaning validation
    • Equipment sterilisation and decontamination
    • Shipping and cold chain
  • Quality Control Aspects
    • Designing a QC strategy
    • Typical QC methods and their limitations
  • Quality Management
    • Essential elements of a PQS for biopharmaceuticals including the importance of change control
    • Audit essentials
  • Key Issues for the QP
    • The technical agreement
    • Science vs compliance
    • The batch review process

We provide an optional post-course assessment that verifies proficiency of all course attendees.
 

Course Tutors

  • Roger Guest - 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 in the development of IMPs and biologicals from formulation to manufacture.

  •  John Johnson - Vice President 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 and margin to ensure perpetual GMP inspection readiness.

Course Fees

Course cost (excluding VAT)  £2,370.00

DISCOUNTS AVAILABLE
Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators,
charities and some self-funding individuals – contact us for details

Have a question or want to book aplace? Contact pharmacourses@nsf.org - you can also register online by clicking below.

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