Joe Cagnassola
Sr Tech Transfer Leader
Joe Cagnassola currently holds the position of a Tech Transfer Leader with Fresenius-Kabi.
In this position, Joe participates in the validation of cleaning, , tech transfers and processes qualifications.
He is active in performing qualifications protocols, writing Master Plans and remediation and optimization efforts of process related activities.
During his career, Joe has held validation position of increasing responsibility with, Cardinal , Mallinckrodt, Pfizer, Merck and Alcon.
Joe has professional interests in ASQ, he obtained his Certified Quality Engineer and Auditor Certifications and has been trained in Six Sigma and Lean. His work supporting various Quality initiatives has provided him a unique experience and insight into the challenges in today’s fast paced pharma environment. Joe earned his Bachelor’s of Science in Biology from Arizona State University.
DAY 1: October 1st, 2025
SESSION: Cleaning Validation Protocol & Documentation
The key to success in any cleaning program is having a cleaning protocol and report that captures the critical steps and provides audit ready documentation. Understanding the cleaning process/program helps the users write polished documentation that stands up to the scrutiny of auditors. This presentation will go step by step through the inception of the cleaning project through the completion of the report. Understanding the process flow will help expedite the Validation time and ensure compliance to internal and external requirements.
Learning Goals for this presentation include: • User Requirements • Pre-Requisites to get started writing • Understanding the Writing Process • Execution and Report Writing.
DAY 2: October 2nd, 2025
SESSION: Cleaning Validation Failures & Troubleshooting
◆ Understanding the cleaning process before starting.
◆ Lack of Risk Assessment, not evaluating the critical to quality attributes.
◆ Establishing Cleaning Limits that meet current standards.
◆ Assuming a state of control.
◆ Poor Documentation, lack of adequate , current procedures.
◆ Listening to the voice on the floor, Training staff.
◆ Compatibility Issues, utilizing improper cleaning methods or detergents.
◆ Residue Recovery Issues that mask failures or are operator dependent.
◆ Time Between Processing and Cleaning: (preparation for worst case cleaning scenarios).
