Introduction to Sterile Product Manufacture for New Starters and Junior Staff
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.
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 Pharmaceutical Consultant with nearly 30 years experience in Pharmaceutical R&D specializing in sterile / parenteral product development including product formulation development, development plans, contamination control, strategic assessments, due diligence activities, specialist auditing of parenteral facilities to cGMP, troubleshooting, microbial contamination and design of parenteral manufacturing facilities.
He spent 24 years at GSK in various technical roles including Director Pharmaceutical Development. Paul is a Chartered Biologist and a Fellow of the Society of Biology and is an expert in pharmaceutical radiation safety, ADME study design and implementation. He has vast regulatory experience with European and FDA agencies and authorship of numerous regulatory submissions including INDs, NDAs, aNDAs, MAAs and CTXs. A proven track record for teaching, mentoring and coaching with many years managerial experience at all levels.
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