What FDA Expects In A Cleaning Validation Report - Key Components and Compliance Tips
Cleaning Validation Training Slide Deck (GMP-Compliant, FDA-Focused)
Price: $59 USD
This downloadable slide deck is a professional, ready-to-use training resource designed to help pharmaceutical, biotech, and medical device companies align their cleaning validation practices with FDA expectations.
Created by a former FDA Investigator and industry compliance executive, this training tool walks your team through the critical elements of cleaning validation—step by step. Whether you're preparing for an FDA inspection or building internal training programs, this deck provides the structure and credibility you need.
This training covers:
- FDA expectations from 21 CFR 211.67 and ICH Q7
- Swab, rinse, and coupon sampling methods
- Worst-case equipment and product selection
- Acceptance criteria and MACO/PDE calculations
- Analytical method validation and recovery studies
- Common deficiencies cited in FDA 483s and Warning Letters
- Real-world enforcement language from an actual FDA Warning Letter
Ideal for:
- QA & QC professionals
- Validation teams
- GMP trainers
- Regulatory affairs specialists
- CDMO/CMO staff preparing for client or FDA audits
Bonus:
Use it as a standalone training tool or integrate it into your broader GMP curriculum. Also pairs well with the Cleaning Validation Knowledge Assessment and Certificate Add-On (available separately).
Format: PDF (19 slides, watermark-free, presentation ready)
Contact: devaughn@fdaid.org for licensing, customization, or live Zoom training options.
A professional, FDA-compliant slide deck covering all critical aspects of cleaning validation. Designed for QA, validation, and regulatory teams, this training includes sampling strategies, MACO/PDE calculations, and real FDA enforcement insights. Perfect for internal GMP training or inspection prep.