- GMP and Compliance
- Pharmaceutical Product Development
- Development and Manufacture of Effervescent Tablets
- HPLC Analytical Method Development and Validation
- Hands-on Tablet Development including the principles of pre-formulation, formulation and process dev
- Introduction to LC-MS for Pharma Industry
- Introduction to Photostability
- Introduction to Sterile Product Manufacture for New Starters and Junior Staff
- Introduction to Sterile Product Manufacture for those with a cGMP basic understanding
- Pharmaceutical Packaging - an introductory course
- Pharmacokinetics in Drug Development - an integrated approach
- Preformulation Studies for Tablet Development
- QbD and Lifecycle Management for Analytical Methods
- Quantitative Bioanalysis using LC-MS for Pharma Industry
- Stability Testing in Biological Product Development and Manufacturing
- Stability Testing in Pharmaceutical Development and Manufacture
- Tablet Formulation Development
- Tablet Formulation Development - Formulation development in practice
- Tablet Process Development, Validation and the Application of QbD
- Technology Transfer
- Pharmaceutical Manufacturing Support
- Pharmaceutical R&D Support
- In-house Training Courses
Introduction to Sterile Product Manufacture for those with a cGMP basic understanding
No Course Dates Currently Available
Overview
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.
Who Should Attend?
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
Course Programme
Day One (9am - 5pm)
Background:
- 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.
