Regulatory And Compliance Training- Active Pharmaceutical Ingredient Manufacturer

Regulatory and compliance training for error identification and correction

The client is a multinational pharmaceutical company headquartered in India and operations in over 20 countries across the globe. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products. In 2015, the client experienced a significant number of non-compliance escalations in its API manufacturing divisions and specifically in the areas of packaging, assembly, production and manufacturing. Major areas of focus were, clinical packaging, manufacturing, and lab testing. The need was to deliver a high-impact regulatory and compliance training solution that could deliver immediate results.

Forward Eye partnered with the client to identify the high-demand roles and skill areas that account for the identified inefficiencies. We designed a series of blended regulatory and compliance training programs that were targeted at the following goals:

  • How Hazard Analysis and Critical Control Points techniques can be used in controlling the processes.
  • How principles can be re-inforced using case studies to deliver practical experience.
  • Learners should be able to prepare a HACCP plan for a selected process upon completion of the training.

The blended learning solution designed to achieve the above goals included:

  1. Corrective and preventive action (CAPA) interactive guides delivered on mobile devices.
  2. Interactive Case-box comprising of searchable case studies around multiple problem scenarios.
  3. PharmaSolve, group sessions on failure investigation and problem solving.
  4. Interactive E-labs for simulation-based practice exercises.
  5. Web based elearning courses delivered on web and CD ROMs.

While the outcomes of the blended training program will be measured within the ambit of a Six-system Inspection Model, slated in the mid of 2016, 2 out of 6 systems have already reported 11% reduction in monthly error reporting within 3 months of the training roll out.

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  • Blended Training Model
  • E-labs
  • Elearning Courses
  • Failure Investigation Kits
  • Interactive Case Studies

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