Evolving C&Q Practices using QRM & Risk- Based Approach
ISPE C&Q Baseline Guide 5 2nd Edition Highlights
Review of the new elements including an integrated approach for developing and executing a commissioning and qualification plan, risk assessments and verification. Description of the new and improved methodologies to test once through verification and use & acceptance reports. The expanded role of Engineering using GEPs and Quality’s focus on that which is deemed critical.
In this presentation, participants will be able to gain an overview of the new C&Q guide, clearly understand of the updates within the revised Baseline Guide, understand the tools provided to projects to drive efficiency and to reduce duplication of C&Q efforts during execution.
Speaker:
Chip Bennett, PMP
Assistant Director, Global C&Q
A QRM SME and the lead CQV Program Development SME for CAI, Chip is a PMIŽ Certified Project Management Professional (PMP) with 19 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and with expertise in risk-based verification, aseptic manufacturing, cleaning validation, quality systems, and owner project management. Chip is responsible for developing and implementing Quality Risk Management (QRM) based Commissioning and Qualification programs and projects, with a particular focus on assessing and training clients regarding development, implementation, and transition to risk-based approaches.
Reception:
Snacks and beverages following the presentation.
Parking:
Please park in the visitor spots located left and right of the MedImmune main lobby entrance, and walk in at the main lobby. ISPE guests will be escorted to the meeting. Please make sure to bring your ID.