Audits and External Quality Assessment in the Laboratory

Course Description

The purpose of this module is to provide the participants with an overview of laboratory assessment, and information about external and internal audits.

What Do Participants Learn?

At the end of this module, participants will be able to:

• develop a process to prepare your laboratory staff for an external audit;
• plan and manage an internal audit;
• discuss how to use results from a laboratory audit;
• advocate for the importance of taking corrective actions.

Who Should Attend?

The course is designed for quality control microbiology professionals, quality assurance or regulatory affairs personnel who have responsibility for the performance of Bioburden, Endotoxin & Sterility Testing or for data review, pharmacists performing sterile compounding.

What Will the Learning Experience Include?

Phase: 1

Introduce

• Comprehensive pre-program activities include:
• Web-based information forms & surveys completed by attendee.
• Direct consultation with the attendee about the expectations.

• During the training, participants engage in data, activities, and conversations that lead to insight and knowledge.
• Participants learn from expert trainers who have both academic and business experiences.
• Highly applicable training content & instructive activities for adding depth to training topics.
• **A half-day site visit for integrating the experience & plan next steps. Opportunities to provide connections, ideas & support.

Phase: 2

Explore & Practice

Phase: 3

Apply

• Apply & sustain the learning experience by using this ongoing support:
• To ensure participant has new skills or behavior progress.
• Optional, fee-based mentoring & coaching with the trainer.
• Training materials & additional documents (e-books, pdf files, presentations and articles)

• Evaluate your training experience by giving us feedbacks and help us to reach our organizational goals.
• Participant's Evaluation
• Trainer's Evaluation

Phase: 4

EVALUATE