INTRODUCTION

Mission for Essential Drugs and Supplies (MEDS) in collaboration with Physikalisch-Technische Bundesanstalt (PTB) and the African Medicines Regulatory Harmonization (AMRH) initiative has organized a unique and exciting training program targeting women Quality Control Technicians, Laboratory Analysts, Calibration Service Providers and other experienced laboratory technicians working in the pharma and food manufacturing industry as well as National Quality Control Laboratories or National Standards Bureaus from the African continent. The training seeks to address the challenge of efficiency in laboratory operations attributed to downtime of equipment and limited availability of qualified service engineers in the region with ability to maintain HPLCs. The objective of the course is to enable optimization of the use of HPLCs in industries to minimize breakdowns by building capacity on good practices and trouble-shooting guides.

ELIGIBILITY

Women scientists attached to pharmaceutical manufacturing units and laboratories, from both private and public sector, including those involved in Quality Assurance, Quality Control, Research, Method Development and pilot plants, domiciled within the Pan African member states.

OBJECTIVE

The course will focus on laboratory testing and its wider scope in quality assurance, with emphasis and focus on detailed techniques for QC equipment/instrument operation, preventive maintenance, troubleshooting, service, diagnosis, and repair.

EXPECTED OUTCOMES

Appropriately trained equipment maintenance personnel who are able to support the production and quality control functions in the local pharmaceutical industry.

A capability to develop effective programs for implementation of equipment preventative maintenance in local firms leading to less incidence of breakdown in critical quality control and production equipment.

Improved efficiency in operations and meeting customer obligations on a timely basis by avoiding delays associated with equipment maintenance.

Reduced reliance on foreign equipment maintenance engineers, which translates to savings for local companies.

COURSE DELIVERY

The course is designed to incorporate blended, self-paced learning with training material prepared beforehand by experts. 

The two-part course involves an e-learning session with three modules (QC-001, QC-002 and QC-003); and a physical practical session. 

In the e-learning session, learners will access the course content on an e-learning platform where lessons, discussions, forums, quizzes and assignments are available. Course facilitators will interact with learners via direct messages and/or discussion forums throughout the virtual sessions. Each module will begin and conclude with videoconference sessions bringing together learners and course facilitators. Participants will be provided with log-in credentials and be able to access the course at any time 24-hours a day. 

The second part of the course will be a practical hands-on session at MEDS’ WHO-Prequalified laboratory in Nairobi, Kenya presenting an opportunity for learners to perform preventive maintenance under the supervision of trained service engineers.

TRAINER

Ms. Mildred Wanyama (MEDS)

Ms. Claire Ogeto (Estec)

Mr. Paul Mwangi (Estec)

PTB CONTACT

Anna Reinhardt, Project Coordinator, anna.reinhardt@ptb.de

Lisa Köhler, Project Assistant, lisa.koehler@ptb.de