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Process Validation Requirements & Compliance Strategies

ComplianceKEY - Governance Risk and Compliance Training   Overview This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Why should you attend this webinar? When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses. Areas Covered in the Session: Global Harmonization Task Force requirements (includes FDA and ISO) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Design Qualification Facilities and utilities Strategies for achieving a robust and reliable process. Typical process validation protocols. Who can Benefit: Managers, Supervisors, Directors, and Vice-Presidents in the areas of: Research & Develop...

Pharmaceutical Quality Risk Management (QRM) Overview

Compliance Key INC  -  Enterprise Risk Management training                                                  STEVEN LAURENZ Steven Laurenz- Chemical Engineering M.S. - Michigan State University Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization.  Webinar Id:   LSHCST001  10:00 AM PT | 1:00 PM  ET   01/24/2018  Duration: 60 mins  Overview Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and Controlling potential risks to quality. However integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization. T...