Overview
This programme is designed specifically for managers and supervisors of staff working in the aseptic manufacturing and filling areas.
The programme utilises the principles of adult learning in that participants are facilitated to develop the principles and practices of Good Aseptic Practices through case studies and problem solving exercises.
Key Subject Areas
The course consists of four core modules of half-day duration. Each may be extended to cover the subject in greater depth and additional modules can be added.
The four core modules are as follows:
- Microbiological Aspects of Sterile Manufacture
- Principles of Sterilisation
- Aseptic Manufacture Management
- Environmental Monitoring
Details of the module content and the learning outcomes are appended.
Course Objectives
The objectives of the course are that delegates will:
- Understand the special requirements of aseptic area operations
- Understand the possible sources of contamination, the associated risk and reliable ways to ensure that contamination does not occur
- Become familiar with the regulatory requirements and industry guidelines associated with aseptic processing
- Understand sterilisation options and methodologies
- Become familiar with the necessary monitoring and validation of aseptic areas, sterilisers and other equipment
Who Should Attend
Managers, supervisors and technical grades responsible for the efficient and effective operation of aseptic pharmaceutical processing facilities.
Duration
The course consists of four half-day modules, each of which may be extended or augmented. Where possible, we suggest that the modules are run in pairs with a gap of a couple of weeks between the two training days to allow for the completion of out-of-class assignments.
Course Format
The course is presented in-house using a balanced mix of presentations case studies and practical sessions, where delegates will be encouraged to learn by self and group discovery. A short quiz is included at the end of each module to test the delegates' comprehension of the subject.
Customisation
A significant proportion of the training course focuses on the client's own operating methods and quality procedures. The Quality Procedures Manual is used in the exercises.
Presenters
SeerPharma will lead the course and facilitate the group activities. The presenters used have many years experience working in the pharmaceutical industry and are able to add many anecdotes and real examples to the course material. Each of the presenters has extensive experience in training and facilitating groups in this type of course.
Course Materials
Delegates will be given a manual containing copies of the slides, accompanying notes and other relevant information.
Following the successful completion of the course, each delegate will be presented with a certificate.
