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.
PROGRAMME
Day One of the course 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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