Introduction to Sterile Product Manufacture for New Starters and Junior Staff (2 day)
28 Nov 2012 - 29 Nov 2012 - Window Conference Venue, 13 Windsor Street, Islington, London, N1 8QG
To provide training to personnel who are new to the Pharmaceutical or Biotech Industries and have no understanding of cGMP and who intend to work with sterile products, development, manufacturing, registration and facilities.
The course will include:
• A comprehensive background in sterile product manufacturing, regulations and facilities. • Adherence to cGMP and the consequences for non-compliance. • How to initiate development of new formulations, manufacturing, environmental and product monitoring. • Modes of sterilization and types of products.
Who should attend?
The course is ideal for new starters or junior staff working in the Pharmaceutical or Biotech industries who will be exposed to a sterile manufacturing facility or who will be involved in the development of new products. This is an introductory course and the level of detail will be as a broad based overview.
• Clinical Trials Manufacturing Scientists
• Development Scientists
• Regulatory Affairs Personal
• Pharmaceutical Production Personnel
• Quality Control and Quality Assurance Personnel
Day One (9am – 5pm)
• What is a sterile product?
• Classification of products.
• Why are they sterile?
Basic microbiology. The Regulatory environment.
• Facilities and processing.
• The impact of personnel and materials
• Environmental Monitoring.
• What is the difference and the impact or viable and non-viable contaminants.
Day Two (9am – 5pm)
• Dosage Forms: syringes, ampoules, vials and others
• Sterilisation: Overview of methods of sterilisation, autoclave, dry heat oven, radiation, filtration and EtOH exposure.
• Aseptic vs. Terminally sterilized, how do you decide?
• Areas of specialization. Where do I go from here?
Paul is a Chartered Biologist, a Fellow Member of the Society of Biology and has nearly 30 years experience in the Pharmacy/Pharmaceutical Industry and left GSK in 2009 to pursue a career as an Independent Consultant. His latter roles at GSK were “Head of Sterile Product Clinical Trial Supplies” and “Director of Product Development”, working on new chemical entities from candidate selection through to market launch and product line extensions. He has broad international experience of product transfers, manufacturing and registrations and can provide an invaluable resource to any company.
Discounted rate for registering and paying before 3 October 2012 - 2 day course £1062.00 (+ VAT if applicable, see VAT NOTES)
Full Fee: 2 day course £1180.00 (+ VAT if applicable, see VAT NOTES)
Discount of 10% applies for booking more than 1 delegate. Discount of 10% applies for booking more than 1 course. Maximum discount received is 15%