Fundamental Industry Knowledge Online Courses

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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.

What You Will Get

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

How to Register ( 668 KB)

General Industry Knowledge Image

General Industry Knowledge

These courses offer general industry knowledge while providing an industry overview, historical background and the basic building blocks to get you started and understand more advanced and specific industry topics.

Product Development Image

Product Development

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.

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Facilities and Equipment

Learn knowledge required to ensure that the critical physical and chemical requirements of drug products are properly understood and managed.

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Information Systems

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.

Productiion Systems Image

Production Systems

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.

Regulatory Compliance

Regulatory Compliance

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.

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Quality Systems

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.

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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.

Sponsorship Opportunities

For more information on ISPE sponsorship opportunities, please contact:

Alisa Pachella
Account Manager
Tel: +1-813-739-2274
apachella@ispe.org

Last Update: 02 April 2014

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