The manufacture of aseptically produced sterile products represents the greatest level of risk to the public and as a result there are numerous requirements that companies must abide by for compliance. This training will cover current regulations as set by the FDA and European Union (EU) GMPs. This will include the main areas of focus by regulatory auditors, expectations for the qualification of equipment and utilities, along with environmental monitoring, media fills and personnel qualification to name a few.
As expected, training of both personnel and management is an increasing area of concern and this seminar will review some proposed reasons for operator error that regulators review to help determine other quality systems that may be impacted depending on the category to which operator error is associated with. Actual cases will be highlighted for some of the reasons listed.
This case study will help you to develop practical cost-effective quality management systems through this training course for pharmaceutical industries to implement effective QMS. We know how important it is to integrate regulatory, market and customer requirements for your complete product range into a streamlined Quality Management System (QMS). Our aim is to help you protect patient health and protect your business from regulatory and commercial risk by Practical Training of quality management systems.
Why You Should Attend:
This workshop will discuss the importance of establishing metrics, as well as, how to utilize those metrics to drive Quality Culture. This course will also discuss the latest draft guidance from the USFDA Office of Manufacturing and Product Quality (OMPQ), EU-Eudralex GMP, PIC(s) GMP and WHO-PQP.
- What is Aseptic process and basics to understand its function
- What is Terminal Sterilization – Why it is important for sterile products?
- Personal behavior in clean room and its impact on Safety of Patient – Avoiding Human errors
- How facility can impact the Risk to Product with reference to Media Fill
- Environmental monitoring – Its importance and controls
- Bio-safety in the Microbiology Lab (Cross Contamination and Risk to Operators) for Pharmaceutical Quality Labs
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Validation Departments
- Process Owners
- Documentation Departments
- Quality Auditors