Best Practice Standards for Pharmaceutical Quality Management of Medicines

This Foundation course provides a guide to quality managements systems for use in all aspects of medicine to ensure consistency of quality of healthcare in accordance with the best practice...

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Duration
40 hours
Course Price
£POA

Learning Objectives

  • Be able to understand and apply Quality Management concepts to decision making in a managerial role in the management of health care provision
  • Review the impact regulations on importation of API and developments and update of the CEP procedure.
  • The course provides guidance on how cGMPs, GCP and GDP apply to their role and responsibilities and how to apply these principles in their daily activities.
  • For the intermediate & advanced, they will be able to apply what they have learned to better manage quality, solve problems, and enhance their continuous improvement programs
  • Understand procedures and equipment design that impact on achieving quality solutions.
  • To understand and appreciate the principals of Risk based assessment that is fundamental to quality solutions.
  • Know the current compliance "hot spots" that international authorities look for when inspecting for GMP/GCP compliant facilities.
  • Know how to better locate regulatory information and to interpret, assess, and make decisions concerning Quality management issues

Course Description

This Foundation course provides a guide to quality managements systems for use in all aspects of medicine to ensure consistency of quality of healthcare in accordance with the best practice standards defined in World Health Organization (WHO) -International Conference on Harmonization (ICH) and Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines.

Topics included in this foundation course are:

- The Principals for provisions for Pharmaceutical Quality Management Systems (PQMS).

- Deviation Handling and Quality Risk Management.

- Commissioning, Qualification and Validation – Which one to use.

- Corrective and Preventative action and Problem CAPA resolution to achieve best operating practice in PQMS

- Improvements in productivity from using “Integrated Quality Management systems

- Management Resolution

Certification Requirements

To qualify for a certificate of competence the following courses must also be satisfactorily completed.

Value of Integrating Data Integrity Checks in PQM Systems

Duration: TBC

Quality Certification for API and Finished Product Batch Release

Duration: TBC

Quality Risk Management - Methods and Techniques

Duration: TBC

Quality By Design for Optimum Process Design

Duration: TBC

Audit Assessor & Lead Assessor Training

Duration: TBC

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