BETCO Consulting

Description: Contamination is a serious concern for the pharmaceutical products. The presence of contaminants such as non-viable particles, micro-organisms and their endotoxins can reduce or even inactivate the therapeutic activity of the drugs and can adversely affect patients taking the contaminated drugs. Furthermore, it is a serious threat to a company’s reputation and success. It can lead to costly product recalls resulting in financial and image losses, loss of product sales, decreased customer confidence, and in many cased, legal; proceeding.

Learning Outcomes: 

At the end of the program, all participants will be able to:

• Explain the meaning of contamination and cross-contamination
• Describe the various types of pharmaceutical contaminants.
• Identify the different modes and sources of contamination.
• Explain the concept of quality risk management and its role in contamination prevention
• Explain the concept and application of FMEA tool in contamination prevention.
• Identify the various prevention and contamination control strategies
• Be familiar with Saudi Food and Drug Authority (SFDA) contamination prevention and control.
• To work with confident on the quality of the product and therefore safety of our patients.

Target Audience: This training course is specially directed to all personal who are involved in contamination prevention and control program. This includes staff from QC, QA, Production, Engineering/maintenance & warehouses. Microbiology staff are the key players in the program and must attend this course. 

Methodology
PowerPoint Presentation & Case studies Exercises