Introduction to Sterile Product Manufacture for those with a cGMP basic understanding
To provide training to personnel who already work in the Pharmaceutical or Biotech Industries who already have a basic understanding of the fundamentals of cGMP and who want to know more about sterile product manufacturing or those individuals whose career paths will bring them into contact with sterile products, manufacturing, registration and facilities.
The course will include:
A background in sterile product manufacturing, regulations and facility constraints. The implications of the actions of those working in sterile product environments. The approach to formulation selection, environmental and product monitoring. A full review of the available and regulatory accepted methods of product sterilisation.
Day One (9am – 5pm)
- What is a sterile product? Classification of products. Why are they sterile?
- Basic microbiology and introduction of the term Sterility Assurance Level (SAL)
- Regulations: Legislation and Governance and Annex 1
- Facilities and process design: Understanding airflows and contamination control philosophies. Air Differentials
- Monitoring Personnel and airborne contamination levels. Viable and non-viable contamination, techniques and the value of monitoring.
Day Two (9am – 5pm)
- Dosage Form Design: The role of the Target Product Profile, syringes, ampoules, vials and other unique delivery systems
- Sterilisation: Methods of sterilisation, autoclave, dry heat oven, radiation, filtration and EtOH exposure. The SAL calculation and interpretation.
- Aseptic vs. Terminally sterilized: Benefits and drawbacks. Registration. Handling implications and further processing.
- Process simulation and Validation: Post registration batches. Validation activities. Impact of ICH and QbD.
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 those already working in the Pharmaceutical or Biotech industries who already have a basic understanding of pharmaceutical cGMP and who wish to gain further insight and training in the requirements specific for the manufacture of parenterals.
- Clinical Trials Manufacturing Scientists
- Development Scientists
- Regulatory Affairs Personal
- Pharmaceutical Production Personnel
- Quality Control and Quality Assurance Personnel