Jenna Carlson
President & Quality Consultant
Jenna Carlson is a Cleaning Validation Subject Matter Expert (SME) with over 24 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 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: 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.
