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
