Pharmaceutical Quality Management - Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible
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Deadline: May 23, 2022 | Date: June 01, 2022
Venue/Country: Online Event, U.S.A
Updated: 2022-05-06 00:36:30 (GMT+9)
Call For Papers - CFP
The use of quality risk management in pharmaceutical operations does not preclude the requirement for a company’s compliance to all applicable regulations. The key is knowing how this process can be best applied to assure compliance and the prioritization and mitigation of identified risks and not as a decision-making process to determine the applicable regulations that must be complied with. This webinar will discuss that pathway.This instructor-led live webinar will discuss the established approach of Pharmaceutical Quality Management as it relates to the relationship between risk management and the pharmaceutical regulations that govern the business. Areas Covered in the Webinar:Quality and risk management definedThe QRM processThe core principles and common practices of quality managementThe risk assessment approachRisk management tools - hazard analysis (PHA), risk evaluation and mitigation (REM), hazard analysis critical control point (HACCP), and FMEAIntegrating QRM into your quality systemThe critical QRM regulations and guidance documents that apply to pharmaceutical manufacturingRegulations that will be Covered:FDA Guidance for Industry – Q8 Pharmaceutical DevelopmentFDA Guidance for Industry – Q9 Quality Risk ManagementFDA Guidance for Industry – Q10 Pharmaceutical Quality SystemKeywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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