Jenna Carlson
President & Quality Consultant
Jenna Carlson is a Cleaning Validation Subject Matter Expert (SME) with over 27 years of experience working in corporate, site, and external manufacturing roles throughout the US, Europe, & Asia. While working in various Validation and Quality Assurance roles, Jenna has gained extensive knowledge of global cGMP requirements and best practices. Jenna has a proven track record, including development of Corporate and Site Cleaning Programs, supporting Regulatory Inspections, Observations, Untitled Letters, Complete Response Letters, and Warning Letters. She has also been instrumental in developing and remediating cleaning programs throughout her career. Jenna has co-authored PDA Technical Reports #29 and #49, Cleaning & Cleaning Validation Volume 1, and various other articles.
DAY 1: May 28th, 2026
SESSION: Regulatory & Inspections Trends Update
◆ FDA, EMA and PIC/S expectations for cleaning validation in 2026.
◆ Key inspection observations and deficiencies seen in 2025.
◆ How to proactively address recurring regulatory findings.
DAY 1: October 1st, 2024
SESSION: Regulatory and GMP aspects for Cleaning Validation
◆ Regulatory emerging trends for industry.
◆ EMA and FDA guidelines.
◆ PIC/S, ICH guidelines.
◆ Current Health Agency observations & warning letters related to cleaning.
