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Subscribe NewsletterRisk Analysis in Pharmaceutical Manufacturing: A Regulatory Overview
Product Id
:
600188
Overview: The issue of risk management or risk assessment is becoming an important tool for decision making in the pharmaceutical industry.
Originally it was important for manufacturers of medical devices, but its use has spread to decision-making in the areas of drugs, biologics, cell therapies, etc. For instance FDA has stated that in validation studies, risk management should be employed to determine what elements should receive careful consideration. Also, when considering deviations, risk analysis should be used to determine the importance of the deviation. While it is impossible to present risk management in one short webinar, this presentation will present an overview of the elements that should be a part of a risk analysis.
Originally it was important for manufacturers of medical devices, but its use has spread to decision-making in the areas of drugs, biologics, cell therapies, etc. For instance FDA has stated that in validation studies, risk management should be employed to determine what elements should receive careful consideration. Also, when considering deviations, risk analysis should be used to determine the importance of the deviation. While it is impossible to present risk management in one short webinar, this presentation will present an overview of the elements that should be a part of a risk analysis.
Areas Covered in the Session:
- What are the regulatory guidance documents that relate to risk analysis?
- What to do at really early stages of product development.
- Hazard Analysis
- Software problems?
- What are the contributors to the hazards? Fault tree Analysis (FTA)
- Evaluating Critical Failures. Failure Mode effect Analysis (FMEA)
- Assessing Risk Severity
- Risk Mitigation or Prevention
- Choosing the assessment team
Who Will Benefit: This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the various types of risk assessment activities that are involved with product manufacturing.
- Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions
- QA/QC personnel who need to plan and execute the work
- R & D personnel who will contribute data
- Project managers for product development studies
- Quality Systems Auditors
- Consultants