Major cGMP Issues: FDA Concerns in 2026

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.

• 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

• 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

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.

• 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.

Ms. Michael Redmond is a Consultant, Speaker and Author. She also conducts ISO Certification Training for PECB. Michael is the Chapter President for Association of Contingency Planners Eastern Great Lake Chapter and an active member of ISSA.

Michael is certified as a Lead Implementer in ISO 27001 Information Security Management, ISO 27035 Security Incident Response, ISO 22301 Business Continuity Management and ISO 21500 Project Management. She is a Certified Instructor for ISO Certification Courses through PECB. Also certified Project Manager PMP, and 2 Master Certifications (MBCP) (FBCI) in Disaster Recovery and CEM Emergency Management

She has consulted in the area of Cyber Security for clients in the arenas of Healthcare, Insurance, Financial and Manufacturing. Her projects have included:

SIEM Security information and event management which is Combining software products and services combining security information management (SIM) and security event management (SEM).

(CSIRT) which is Cyber Security Incident Response Programs, Plans, Playbooks, Training and Testing.

Audit of CSIRT programs and documentation.

Information Security Programs and Implementation.

She has 2 books which are coming out in 2016 and are being published by one of the Top International Publishers in the world. The first is a Cyber Security book and the second is a Business Continuity and Disaster Recovery book Michael has a series of Audio Training that receive CEU's from Disaster Recovery Institute (DRI) and other certifying organizations.

They are: Cyber Security Training for - 6 CEU's. Business Continuity Management for 20 CEU's. www.rwknowledge.com Michael's been honored as Top Woman in her field at a White House Luncheon and was selected out of the world to write the prolog for the chapter on RISK Management by the United Nations for their Disaster Book which was given to the head of state for every UN member nation. She has recently been named on the list of "Women of Distinction for 2015" by Women of Distinction Magazine for her work in Cyber Security. She was selected to speak on Cyber Security Incident Response and SIEM at such recent conferences as: International ISSA Conference in Chicago. NYS Cyber Security Conference - Co Spoke with Acting CISO for New York State. ISACA Western New York Conference. Metric Stream Round Table in New York City.