Pharma-Ready QC Microbiology Training – cGMP Compliant, Fully Customizable
Ensure your Quality Control (QC) and manufacturing personnel understand the microbiological principles that safeguard every batch.
This 1.5-hour training deck provides a ready-to-use introduction to QC Microbiology, perfect for annual cGMP training or new-hire onboarding under FDA 21 CFR 211.25 requirements.
Learning Objectives:
The learner will gain an understanding of the importance of sterile production in sterile injectables and the consequences of non-compliance for the end user of the product.
The learner will understand the cGMP regulations regarding sterile production, which work to ensure that safe and effective drugs come to market.
The learner will understand what steps (Company) takes to maintain a sterile, clean, and safe product for the patient.
The learner will gain a basic understanding of the microbial world and how their everyday actions in the workplace can contribute to a sterile environment.
This comprehensive presentation was created entirely without AI assistance and comes complete with a detailed facilitation script. Designed for a 1.5-hour session, whether delivered in person or virtually, this 34-slide deck provides an engaging, visually rich overview of microbiological principles relevant to pharmaceutical manufacturing.
All visuals are sourced from royalty-free collections to ensure full copyright compliance, and multiple reputable references are included for transparency and fact-checking. The presentation also comes with a course evaluation survey and can be fully customized to align with your company’s specific training requirements.
Topics Covered:
The impact of microbial contamination in pharmaceutical manufacturing
Introduction to bacteria
Introduction to fungi
Cleanroom fundamentals
Quality control microbiology testing
Aseptic vs. terminal sterilization
Cleaning and disinfection best practices
Compliance Alignment
21 CFR 211.25 requires every person engaged in drug manufacturing to be trained in current Good Manufacturing Practice (cGMP) “on a continuing basis.”
QC Microbiology training ensures personnel are qualified to prevent contamination and maintain data integrity. This module helps companies demonstrate compliance while improving real-world understanding across teams.
Meets FDA expectations for training under:
21 CFR 211.25(a): Personnel qualifications and continuing GMP education
21 CFR 211 Subpart I: Laboratory Controls
21 CFR 211.192: Production and laboratory record review
(Supports, but does not replace, site-specific SOPs or qualification requirements.)
Customization Options
Self-Customize:
Download instantly and adapt the deck to your SOPs, terminology, or site branding.
“Customize For Me” Add-On:
Our team will tailor the content for your organization: adding logos, references to your aseptic processes, and quality messaging to match your training style.
Who It’s For
QC & QA associates
Microbiology laboratory technicians
Manufacturing and packaging personnel
Training & Quality Managers seeking cGMP-aligned content
Change Log
We make every effort to ensure our training content remains accurate and current. Updates or revisions may be made to materials after purchase, and all changes will be documented here with a summary and date of update. Your purchase includes lifetime access to all future updates of this product. Please note that newly developed supplemental materials are not considered updates and may be offered as separate, optional purchases.
Initial Creation: November 2025
Disclaimer: This module supports, but does not replace, your full obligation under cGMP or site-specific SOPs. Please adapt as required.
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