Biologically Derived Products - Manufacture, Testing and Compliance Challenges

2 Day/s

CPD Hours: 14

Online, In-house

The field of biologically derived medicines is expanding. With an increasing number of products being marketed, biological products bring unique challenges to the manufacturing process.

Biological products have unique challenges and constraints as compared to traditional chemical products. The impact of not understanding and controlling these elements will impact the new product registration process and the ongoing manufacturing process.

This interactive course provides insight into the GMP regulations for biologically derived products, the testing and manufacturing challenges and the regulations for these cutting edge products. Day One of the course focuses on Biological Processes and covers the following topics and Day Two, covers Sterile Processes applicable to Biological Products.

Relevant to those who need to gain a better understanding of the challenges in GMP manufacture of biological products, the regulatory position of biological products and how GMP regulations are managing the rapid technological developments. Particularly those in Production, QC and QA working at Manufacturers and QC testing houses handling biologically derived products.

Day One 

Focuses on Biological Processes and covers the following topics:

  • Regulations - 2001/83 & 2001/83 and EU GMP Annexes 2, 4, 5 and 14
  • Cell Culture - Microbial and Mammalian
  • Vaccines - Human and Animal
  • Blood Products
  • ATMPs
  • Biosimilars
  • Product Testing - Validation and Performance
  • Product Distribution

Day Two

Covers Sterile Processes applicable to Biological Products, as follows:

  • Introduction
  • Regulations
  • Facility design and operation
  • Types of Sterilisation -Terminal Sterilisation and Aseptic Processing
  • Aspects of Filtration
  • Environmental Monitoring

    By attending this course, you will :

    • Gain a better understanding of the challenges in GMP manufacture of biological products
    • Understand the regulatory position of biological products
    • Know how GMP regulations are managing the rapid technological developments

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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

Adam Slater

Adam is an experienced Pharmaceutical/Biopharmaceutical QA professional, with over 35 years GMP, GDP, ISO 9001, Pharmaceutical Quality Systems, and audit experience. Adam is a Microbiology and Chemistry Graduate and started his career in QC laboratories within the NHS, before moving into private industry. He then moved into QC and QA roles within different contract manufacturing companies. In 2004 he joined Wyeth (now Pfizer). He also completed his EU Qualified Person training during this time and within Wyeth led a team responsible for contract manufacturing operations in Europe, Middle East, and Africa. He has held positions in QC, QA, Regulatory, R&D, Operations, Technical Support and Validation. He has a wide experience of dosage forms and specialises in Sterile Manufacturing and US FDA PAI readiness and remediation. Adam established his own consultancy in July 2010. He is an active, highly experienced international auditor and has worked extensively in India, China, Pakistan, Middle East, Japan, and the USA. Adam has worked with a wide range of personnel and across many countries. He has also held senior leadership and board roles and throughout his career he has promoted a positive ‘Quality Culture’. He is passionate about passing on his personal experience to others, through education, coaching, mentoring, and training.

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