Current Good Manufacturing Practices (cGMP) are the FDA's rules for making sure pharmaceutical and biotech products are safe, effective and of consistent quality. They apply at every stage of manufacturing, from facility design to process controls, and keeping up with FDA expectations helps protect patients and avoid recalls and penalties.
This 60-minute cGMP compliance webinar reviews the most pressing cGMP issues FDA has identified in 2026. It covers current enforcement priorities, inspection trends, recurring compliance pitfalls and practical ways to meet regulatory expectations.
Using real-world examples and case studies, you'll see how to manage risk proactively, raise operational standards, close compliance gaps and build a culture of accountability across your organization.
WHY SHOULD YOU ATTEND?
FDA scrutiny of cGMP compliance continues to focus on key areas of concern in 2026. Keeping up with these issues helps you avoid warning letters, protect product integrity and safeguard your organization's reputation, instead of discovering gaps during an inspection.
The session suits quality assurance, regulatory affairs, compliance, manufacturing, clinical operations and facility staff at pharmaceutical, biotech, contract manufacturing, medical device, OTC and dietary supplement companies.
AREA COVERED
- cGMP principles and FDA enforcement priorities in 2026
- Common inspection findings and recurring violations
- Strategies for preparing for and passing FDA inspections
- Updates on facility requirements, process validation and documentation practices
- Risk-based approaches to ongoing compliance and product quality
- Case studies of cGMP compliance failures and lessons learned
- Best practices for staff training and maintaining a compliance culture
LEARNING OBJECTIVES
- Describe core cGMP principles and FDA's enforcement priorities in 2026
- Recognize common inspection findings and recurring violations
- Prepare your site to pass an FDA inspection
- Apply current expectations for facilities, process validation and documentation
- Use risk-based approaches to sustain compliance and product quality
- Learn from case studies of cGMP failures
- Strengthen staff training and compliance culture
WHO WILL BENEFIT?
- Quality Assurance Managers
- Regulatory Affairs Professionals
- Manufacturing Supervisors
- Compliance Managers
- Clinical Operations Personnel
- Facility Managers
- Target Companies:
- Pharmaceutical Manufacturers
- Biotechnology Firms
- Contract Manufacturing Organizations (CMOs)
- Medical Device Manufacturers
- Over-the-Counter Product Manufacturers
- Nutraceutical and Dietary Supplement Companies
- Target Associations/Societies:
- Pharmaceutical Quality Organizations
- Regulatory Compliance Networks
- Medical Device and Biotechnology Associations
- Controlled Substances Management Groups industry-specific GMP Training Coalitions
- Target Audience to market:
- Individuals in quality assurance, regulatory affairs, manufacturing operations, or compliance who are responsible for meeting cGMP standards and navigating FDA requirements.
FDA scrutiny of cGMP compliance continues to focus on key areas of concern in 2026. Keeping up with these issues helps you avoid warning letters, protect product integrity and safeguard your organization's reputation, instead of discovering gaps during an inspection.
The session suits quality assurance, regulatory affairs, compliance, manufacturing, clinical operations and facility staff at pharmaceutical, biotech, contract manufacturing, medical device, OTC and dietary supplement companies.
- cGMP principles and FDA enforcement priorities in 2026
- Common inspection findings and recurring violations
- Strategies for preparing for and passing FDA inspections
- Updates on facility requirements, process validation and documentation practices
- Risk-based approaches to ongoing compliance and product quality
- Case studies of cGMP compliance failures and lessons learned
- Best practices for staff training and maintaining a compliance culture
- Describe core cGMP principles and FDA's enforcement priorities in 2026
- Recognize common inspection findings and recurring violations
- Prepare your site to pass an FDA inspection
- Apply current expectations for facilities, process validation and documentation
- Use risk-based approaches to sustain compliance and product quality
- Learn from case studies of cGMP failures
- Strengthen staff training and compliance culture
- Quality Assurance Managers
- Regulatory Affairs Professionals
- Manufacturing Supervisors
- Compliance Managers
- Clinical Operations Personnel
- Facility Managers
- Target Companies:
- Pharmaceutical Manufacturers
- Biotechnology Firms
- Contract Manufacturing Organizations (CMOs)
- Medical Device Manufacturers
- Over-the-Counter Product Manufacturers
- Nutraceutical and Dietary Supplement Companies
- Target Associations/Societies:
- Pharmaceutical Quality Organizations
- Regulatory Compliance Networks
- Medical Device and Biotechnology Associations
- Controlled Substances Management Groups industry-specific GMP Training Coalitions
- Target Audience to market:
- Individuals in quality assurance, regulatory affairs, manufacturing operations, or compliance who are responsible for meeting cGMP standards and navigating FDA requirements.
