The pharmaceutical industry operates under stringent regulatory expectations to ensure that drug products are consistently produced and controlled to meet quality standards appropriate for their intended use. Good Manufacturing Practices (GMP) form the backbone of these expectations, governing everything from facility design and equipment qualification to documentation, training, and quality oversight.

Quality Assurance (QA) serves as the overarching system that ensures GMP compliance is not only achieved but sustained. It integrates processes, procedures, and behaviors to prevent errors, ensure data integrity, and maintain product quality throughout the lifecycle. As regulatory scrutiny increases globally and supply chains become more complex, organizations must strengthen their QA systems and deepen their understanding of GMP principles to remain compliant and competitive.

This 60-minute webinar provides a focused and practical overview of Quality Assurance (QA) and Good Manufacturing Practices (GMP) as they apply to drug production environments. The session is designed to bridge the gap between regulatory requirements and day-to-day operational execution, emphasizing how quality systems function in real manufacturing settings.

The webinar begins with a foundational overview of GMP principles, including their regulatory basis and global alignment across agencies such as the FDA and EMA. Participants will gain a clear understanding of how GMP requirements translate into operational controls within pharmaceutical manufacturing, including facility design, equipment qualification, process validation, and environmental control.

The session then transitions into the role of Quality Assurance, highlighting how QA systems govern and oversee GMP compliance. This includes batch record review, deviation management, CAPA systems, change control, and internal audits. Special emphasis is placed on the concept that QA is not a department but a system that integrates across all functions.

A critical portion of the webinar focuses on documentation and data integrity. Participants will explore the principles of ALCOA+ and how poor documentation practices can lead to significant compliance risks. Real-world examples will illustrate how seemingly minor errors can escalate into regulatory findings.

The webinar also addresses human factors in GMP environments, including the role of training, behavior, and organizational culture in maintaining compliance. Participants will learn how operational discipline, procedural adherence, and effective training programs contribute directly to product quality and inspection readiness.

Finally, the session covers inspection readiness and regulatory expectations. Attendees will gain insight into how inspectors evaluate GMP systems, what they look for during inspections, and how to prepare effectively. The webinar concludes with practical strategies for strengthening QA systems and sustaining compliance in evolving regulatory landscapes.

• Overview of GMP regulations and global expectations 
• Core principles of Good Manufacturing Practices in drug production 
• Role and structure of Quality Assurance systems 
• Documentation practices and data integrity (ALCOA+) 
• Deviation management, CAPA, and change control 
• Process validation and quality oversight 
• Human error and behavioral considerations in GMP environments 
• Training requirements and operational discipline 
• Inspection readiness and regulatory expectations 
• Common GMP compliance gaps and how to avoid them

Regulatory agencies such as the FDA, EMA, and global health authorities are intensifying inspections, with a growing focus on data integrity, documentation practices, and quality system effectiveness. Many organizations believe they are compliant until an inspection reveals gaps that lead to costly observations, warning letters, or even production shutdowns.

The reality is that GMP compliance is not just about having procedures in place it is about how those procedures are executed in real-world operations. Human error, inadequate training, poor documentation practices, and weak quality oversight continue to be leading causes of regulatory findings. Even experienced professionals often misunderstand how QA systems should function in practice, particularly in dynamic manufacturing environments.

This webinar addresses the critical gap between theory and execution. It provides a clear, practical understanding of how QA and GMP intersect in drug production and what regulators expect to see during inspections. Participants will gain insight into common compliance failures, how to prevent them, and how to build systems that withstand regulatory scrutiny.

If you are responsible for manufacturing, quality, compliance, or oversight, failing to fully understand GMP expectations can expose your organization to significant regulatory and operational risk. This session equips you with the knowledge needed to proactively identify weaknesses, strengthen your quality systems, and ensure consistent compliance.

• Quality Assurance Professionals 
• Manufacturing and Production Managers 
• Quality Control Analysts 
• Regulatory Affairs Professionals 
• Validation and Compliance Specialists 
• Training and Documentation Managers 
• Operations Supervisors
• Pharmaceutical Manufacturers 
• Biotech Companies
• Contract Manufacturing Organizations (CMOs) 
• Generic Drug Manufacturers 
• Specialty and Sterile Product Manufacturers

During the Q&A session following the live event, ask a question and get a direct response from our expert speaker.

Important Notice for Our “Live” Attendees: If you have enrolled in the “Live Webinar,” you will get your instruction kit before 24 hours of the live class.

For Recorded and E-transcript Participants: If you have signed up for the “Recorded” class or for the “E-transcript,” you will get access to the “Recording link” or the “PDF” within 24-48 hours of the live class.

SPEAKER

Charles H. Paul

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Charles Paul is the President of C.H. Paul Consulting, Inc., a technical writing and management consulting firm now in its 25th year. With a 30-year career as an instructional designer, he specializes in creating unique, blended training solutions that deliver measurable results at accelerated rates. His primary industry focus includes life sciences, cosmetics, consumer products, and food and beverage sectors.

Charles’s extensive background includes serving in the U.S. Army’s Training and Doctrine Command and as the National Maintenance Training Director for Johnson & Johnson Baby Products Company. Throughout his career, he has designed training programs for a wide range of fields, including information technology, R&D, manufacturing, and human resources, while specializing in pre- and post-merger operational evaluations.

A seasoned instructor, Charles regularly leads workshops on topics such as Project Management, Scientific and Technical Writing, and Leadership Development. He holds degrees in Instructional Design and Business Administration and is a distinguished graduate of several military programs, including Instructional Systems Design at the U.S. Naval Training Center and Training Material Development at the U.S. Army Training and Doctrine Command.

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