Hello, Would Your Data Stand Up to an Inspection?

Explore ALCOA+, FDA observations and the failures behind data integrity findings.

THE DATA IS THERE. BUT, CAN YOU TRUST IT? In a regulated environment, a result is only as defensible as the data behind it. Data integrity failures can turn routine records into regulatory findings. BUILD DATA THAT STANDS UP TO SCRUTINY Data integrity extends beyond whether a number is correct. It encompasses how data is generated, recorded, maintained, reviewed and protected throughout its lifecycle. This workshop examines the principles and regulatory expectations behind effective data integrity programs, with lessons drawn from FDA warning letters and Form 483 observations. 01 UNDERSTAND Explore data integrity principles, ALCOA+, and the regulatory framework behind them. 02 IDENTIFY Recognize common causes of data integrity failures and weaknesses within existing systems. 03 PREVENT Apply data integrity by design to build stronger, more defensible processes. LESSONS FROM GMP INSPECTIONS What Regulators Find... TELLS YOU WHAT TO PREVENT. FDA WARNING LETTERS | FORM 483s | DATA INTEGRITY FAILURES Examine regulatory observations to understand where data integrity systems break down and how stronger controls can help prevent similar failures. DESIGNED FOR REGULATED ENVIRONMENTS For the people responsible FOR THE DATA Quality Assurance • Regulatory Affairs • Compliance • Data Management For professionals working with data integrity and regulatory requirements across pharmaceutical, food and cannabis environments. DATA INTEGRITY IS BUILT BEFORE AN INSPECTION. BE READY TO DEFEND THE DATA. Avoiding Data Integrity Failures: Lessons from GMP Inspections CHOOSE HOW YOU'D LIKE TO LEARN: Live Workshop Join the next instructor-led workshop. ____________ October 15, 2026 JOIN LIVE → Recorded Workshop Learn on your schedule with the latest updated recorded session. ____________ On-Demand Access GET RECORDED ACCESS → Live + Recorded Attend live AND get recorded version for continued access. ____________ Oct 15 + On-Demand GET BOTH → *Recorded Workshop orders will be processed within 2-3 business days of purchase, independently of the live workshop date. VIEW WORKSHOP OPTIONS → Interested in this workshop? Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

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A CAPA Is Only as Good as Its Root Cause

See how Lean problem-solving can strengthen the path from deviation to corrective action.

CORRECTIVE & PREVENTIVE ACTION YOU FOUND A ROOT CAUSE. But can you prove it’s the right one? A strong CAPA requires more than an explanation. It requires a clear path from the problem to the process, the root cause and an action that can be verified. EXPLORE THE WORKSHOP → THE REAL WORK STARTS BEFORE THE CORRECTIVE ACTION. What happened? Where in the process did it happen? What conditions allowed it to happen? and, What needs to change so it does not happen again? This workshop uses Lean problem-solving principles to work through those questions systematically, from defining the problem and mapping the process to identifying root causes, developing corrective actions and confirming results. DON’T JUST CLOSE THE CAPA.  BUILD THE CASE BEHIND IT.   A PRACTICAL WAY THROUGH CAPA WORK THE PROBLEM, STEP BY STEP. 01 DEFINE Frame the problem clearly. 02 TRACE Examine the process and identify non-value-added activities. 03 FIND Move beyond “human error” to identify the underlying root cause. 04 FIX Develop corrective actions and confirm the results. THE QUESTION ISN’T JUST “WHAT CAUSED THE DEVIATION?” IT’S “WHAT IN THE PROCESS NEEDS TO CHANGE?” WHO SHOULD ATTEND QUALITY ASSURANCE INTERNAL AUDIT REGULATORY COMPLIANCE For professionals across pharmaceutical, biotechnology, medical device and other regulated environments, and anyone looking to strengthen their practical understanding of CAPA. ✓ CERTIFICATE OF ATTENDANCE  All participants receive a Certificate of Attendance upon completion. CHOOSE HOW YOU'D LIKE TO LEARN: Live Workshop Join the next instructor-led workshop. ____________ October 29, 2026 JOIN LIVE Recorded Workshop Learn on your schedule with the latest updated recorded session. ____________ On-Demand Access GET RECORDED ACCESS Live + Recorded Attend live AND get recorded version for continued access. ____________ Oct 29 + On-Demand GET BOTH *Recorded Workshop orders will be processed within 2-3 business days of purchase, independently of the live workshop date. CORRECTIVE & PREVENTIVE ACTION FIND THE CAUSE. FIX THE PROCESS. KEEP IT FIXED. Live • Recorded • Live + Recorded VIEW WORKSHOP OPTIONS → Interested in this workshop? Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

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