March 3 - 11, 2026 | 4 Modules | US Eastern Time: 11 AM to 1 PM | GMT: 4 PM to 6 PM
This comprehensive GMP Master Class delivers a structured, end-to-end view of how modern Good Manufacturing Practices must function in real operations to satisfy FDA expectations. Designed for professionals working directly within regulated environments, the course moves beyond theory and regulatory citations to focus on execution — how procedures, documentation, facilities, people, and quality systems work together to demonstrate control and consistency. Participants begin by establishing a strong foundation in how FDA interprets compliance under 21 CFR Parts 210, 211, and 820. Rather than treating regulations as abstract requirements, the program explains how investigators evaluate systems during inspections, how evidence is collected, and why certain behaviors consistently trigger observations. This understanding helps attendees see their operations through the eyes of regulators.
From this foundation, the course addresses the most common failure points seen across the industry: weak documentation practices, poor data integrity controls, contamination risks, and ineffective investigations. Each topic is approached practically. Participants learn how to design records that are clear and defensible, how to implement ALCOA+ principles consistently, how to prevent cross-contamination through disciplined facility and personnel controls, and how to conduct investigations that identify true root causes rather than superficial explanations. Special emphasis is placed on creating sustainable systems. Compliance is not achieved through last-minute audit preparation; it is built into daily routines, training, and management oversight. Attendees learn how to embed inspection readiness into everyday work so that documentation, decisions, and controls naturally withstand scrutiny. By the end of the series, participants will understand not only what GMP regulations require, but how to operationalize them effectively. They will leave with practical techniques, templates, and behaviors that reduce risk, strengthen quality culture, and improve inspection outcomes.
Module 1: Foundations of GMP & Inspection Readiness (March 3, 2026)
Module 2: Data Integrity & Documentation Excellence (March 4, 2026)
Module 3: Contamination Prevention & Environmental Control (March 10, 2026)
Module 4: Deviations, CAPA & Change Control (March 11, 2026)
Good Manufacturing Practices (GMPs) form the operational backbone of pharmaceutical, biotech, and medical device manufacturing. While most organizations have procedures and quality systems in place, many continue to struggle with inconsistent execution, documentation gaps, data integrity risks, contamination events, and weak investigations. These issues frequently surface during FDA inspections and often lead to Form 483 observations, Warning Letters, product recalls, and costly remediation efforts.
Modern regulators expect more than written policies — they expect demonstrable control, traceable evidence, and disciplined daily behaviors. This master class provides a practical, hands-on interpretation of GMP requirements and translates regulatory language into real-world operational practices teams can apply immediately.
Why This Training MattersFDA does not cite companies because they lack SOPs. They cite companies because the SOPs are not followed, not documented, or not defensible. Most organizations believe they are “GMP compliant” — until an inspection proves otherwise. A missing logbook entry. An undocumented decision. A shared password. A backdated correction. An incomplete deviation investigation. These small operational habits quickly become major findings when viewed through an investigator’s lens. And once data integrity or process control is questioned, everything becomes suspect: batch records, test results, training records, even management oversight. At that point, the burden of proof shifts to you. You must demonstrate control — not claim it. The cost of poor GMP discipline is significant: delayed product release, rejected batches, rework, recalls, Warning Letters, consent decrees, or import alerts. But perhaps more importantly, weak practices put patients and your company’s reputation at risk. This program is intentionally practical. Instead of repeating regulations, it focuses on what people must actually do differently on the floor, in the lab, and in the quality unit to withstand regulatory scrutiny. You will learn how inspectors think, what they look for first, and how to design systems that naturally generate proof of compliance. If you want fewer surprises during inspections, stronger documentation, cleaner investigations, and a culture that consistently “does it right the first time,” this master class gives you the tools to get there. | Who This Training Is Designed For
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MODULE 1: Foundations of GMP & Inspection Readiness March 3, 2026 | 2 Hours AGENDA:
| MODULE 2: Data Integrity & Documentation Excellence March 4, 2026 | 2 Hours AGENDA:
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MODULE 3: Contamination Prevention & Environmental Control March 10, 2026 | 2 Hours AGENDA:
| MODULE 4: Deviations, CAPA & Change Control March 11, 2026 | 2 Hours AGENDA:
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Charles H. Paul is the President of CHP Consulting LLC – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 25 years and has published numerous white papers on varies subject from project management and technical writing to regulatory compliance in the life sciences. The firm works with both domestic and international clients designing solutions for complex training and documentation issues within the life sciences.