Would you like to diversify your knowledge, from product development through manufacturing?
You can do so with ISPE’s pre-recorded courses, which were developed and reviewed by expert instructors and international regulatory advisors.
Each 30 to 90-minute course gives you an interactive learning experience:
- A downloadable course presentation for note taking.
- Learning reviews/assessments highlighting important points.
- Links to regulatory and industry information.
- An online resource handout as a quick reference for all the web links discussed.
- ISPE CEUs for each course you take
Through the interactions of multi-disciplinary functions and the scientific application of experimental design methodologies, implement a process to reproducibly and economically manufacture a product.
- Formulation, Clinical Phases, and Manufacturing
- Technology Transfer
- Production Scale-up and Optimization
Facilities and Equipment
Learn knowledge required to ensure that the critical physical and chemical requirements of drug products are properly understood and managed.
- Design and Construction/Installation
- Commissioning and Qualifications as a Risk Management Strategy
- Operation and Maintenance
- Controls and Automation
Study the basic computer system lifecycle model, including activities and software quality assurance practices in each phase, from data integrity and security measures, such as back-up archiving and retention requirements for data management systems with product and financial impact.
Gain the knowledge of the full range and scope of unit operations and production steps for manufacturing APIs and both small molecule and biologic pharmaceuticals; and the building and critical process utility systems that support the manufacturing process.
- Production Unit Operations drug (small molecule) and biologics
- Production Management
- Production Control
Gain a fundamental understanding of (a) international regulations and guidance issued by regulatory bodies and coalitions which shape the world’s current pharmaceutical-related requirements and future directions, and (b) the application of regulations and industry-generated guidance for global harmonization of compliance and product registration.
Gain the knowledge of the role and elements of a quality management system and its impact within the overall risk management approach, as well as its implementation in a scientific and pragmatic manner.
Supply Chain Management
Gain the Knowledge of the key components of supply and distribution chains and their financial impact; the systems required for dynamically controlling and auto mating receipt, storage and dispensing of raw materials, and packaging materials. Storage distribution of finished products, so that the integrity of the product is not impaired by any of these processes.