Data-Driven Risk Management:

A practical approach to minimize subjectivity in line with ICH Q9 (R1)


Presented by: Nathan Temple, Global Director C&Q, CAI

Learn about key initiatives, industry drivers and trends that are transforming project delivery with a focus on operational readiness and speed to patient. Project delivery timelines continue to be scrutinized and there are powerful ways to shift validation off the critical path. More importantly, through Quality Risk Management based integrated C&Q industry is seeing significant schedule reduction WITH increased manufacturing performance and product quality.  This topic highlights many of the deeper discussions planned for the full validation university program.

Top Reasons To Attend:

• Inform on how senior leadership views the problem of harmonized & holistic manufacturing performance
• Learn how a focus on operational readiness is significantly accelerating project delivery
• Discussion on how industry is shifting C&Q off the critical path
• Key regulatory guidance including Q9 and CSA and recent ISPE GAMP5 and GEP guide updates
• How QRM and GEPs empower you to make small but substantive changes within your current program
• Drivers and initiatives you can use to justify re-looking at how you execute C&Q

Register

SPEAKERS


Nathan Temple

Global Director C&Q, CAI

Nathan Temple serves as the CAI CQV Business Area Lead, is a PMI® Certified Project Management Professional (PMP) and licensed Professional Engineer with 20 consecutive years of experience in the fields of start-up, maintenance, commissioning, and qualification. Nathan has extensive engineering, test execution, and project management experience with a wide variety of systems and equipment. Nathan is a computer system validation subject matter expert providing project consulting and support. He is chair of the ISPE C&Q Community of Practice Steering Committee.  Nathan is a sought-after expert in the areas of C&Q program implementation and optimization with emphasis on integrated C&Q and operational readiness.


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