In this day and age, more and more laboratories are run like businesses, where success is driven by credibility.
In order to be credible in the current competitive environment, your laboratory must:
- Produce reliable and accurate results with unambiguous test reports
- Deliver correct information to the correct customer in a timely manner
- Perform economically and efficiently
- Be able to retrieve historical records and data
- Operate independently in quality assessment
- Withstand audits and inspections
Critically, the loss of credibility in a laboratory leads to customer scepticism and a loss in confidence of your capabilities. Without Good (Quality Control) Laboratory Practices – G(QC)LP – you are left focusing on “defending” results, and regulatory or external pressure which distract personnel from value-adding and cost-effective operations.
This modules of this course will help you and your laboratory perform successfully by providing you with knowledge and the understanding needed to establish and maintain G(QC)LP.
Content
We offer a comprehensive set of eight (8) modules addressing the major laboratory concepts, requirements, techniques and procedures:
- Introduction to Good (Quality Control) Laboratory Practices
- G(QC)LPs in a Regulated Environment
- IQ/OQ for Laboratory Equipment
- Analytical Method Validation
- Biological Assay Validation & Control
- Basic Statistics for Quality Control Laboratories
- Pharmaceutical Sampling Plans
- Stability Programs
Participants
You will benefit from this training if you are a regulated laboratory analyst or supervisor, or if you have a general interest in GxP and laboratory practices.
Format and Course Length:
All eight modules make a 3-day program, but you can choose specific modules that meet your needs for a shorter course.
The training involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.
