Quality Risk Management for Sterile Products Training

Did you know we also offer quality risk management (non-dosage form specific) training? Improve your decision-making skills and better protect your company and the patient. View course details and dates.

This course is designed to help QA, production and engineering staff make the right decisions when the unexpected occurs. Through a series of real-life scenarios, we train you to use a combination of risk-assessment techniques to gauge the risk to product and patients. Based on what you’ve learned, you’ll be asked to take the most appropriate actions to ensure that sustainable fixes are put in place to prevent reoccurrences. We can’t stop all problems from occurring, but we can help you to feel confident in dealing with them when they do.

Justifiable vs. Unjustifiable Risks

When things go catastrophically wrong, risk-based decision-making is relatively straightforward. However, things are rarely so black and white. The biggest challenge facing anyone in sterile products manufacture is dealing with the grey area problems that arise almost daily. These issues require decisions that are:

• Scientifically justifiable
• Based on an objective and realistic assessment of risk
• In compliance with regulatory requirements and expectations
• Good for your business

The objective of this risk assessment for sterile products course is to help you to improve your problem-solving and decision-making skills. The skills you learn could save your company millions in rejected product, regulatory censure or lost reputation.

Through practice, you are given the skills and confidence to deal with any situation and make the right risk-based decision no matter how challenging the scenario.

For example:

• High environmental counts in a Class A (viable and nonviable)
• Unexpectedly high pre-filtration bioburden counts
• Momentary drop in temperature and pressure during autoclave cycle
• Filling room occupancy higher than has been simulated during media fills
• HEPA filter integrity test failure during requalification
• Sterile filtration of solution takes longer than is permitted in the manufacturing instruction
• Higher than normal reject rate during visual inspection
• High microbial counts on hands of operator detected at exit monitoring
• Unplanned deviation from approved sterilizer loading pattern
• And many more

You also learn the right tools to use in the right situation to select the right data sets for each scenario.

This course provides a unique opportunity to improve your decision-making skills.

The Theory

Lectures cover essential information on current EU and U.S. requirements for:

• Cleanrooms and controlled environments
• Sterilization processes
• Environmental monitoring (viable and nonviable)
• Process simulations
• Container integrity testing and visual inspection
• Environmental monitoring
• Personnel monitoring
• Cleaning and sanitization
• Risk management principles and the major risk assessment techniques, HACCP and FMEA

The Practice

In small working groups using the tools and techniques covered, you make decisions on a range of scenario situations.