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.
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:
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.
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.
Lectures cover essential information on current EU and U.S. requirements for:
In small working groups using the tools and techniques covered, you make decisions on a range of scenario situations.
Whether you need to meet EU, FDA or other regulatory agency needs, this course provides the knowledge, skills and tools to succeed.
Gain insight into cGMP expectations concerning a range of bioprocesses including seed/cell banking, serial and bulk cultivation, harvesting and more.
This highly interactive workshop provides tools and techniques to improve your decision-making skills and better protect your company and the patient.