Major cGMP Issues: FDA Concerns in 2026

Current Good Manufacturing Practices (cGMP) are essential guidelines established by regulatory agencies like the FDA to ensure the quality, safety, and efficacy of pharmaceutical and biotech products. These standards govern every stage of manufacturing, from facility design to process controls. With the FDA’s ongoing updates and enforcement actions, understanding cGMP expectations is critical for maintaining compliance, protecting public health, and preventing costly recalls or penalties.

• FUD Liner: Are your compliance gaps leaving you vulnerable? Don’t wait for an FDA inspection to discover unmet expectations that could result in devastating fines or production halts.

• Overview of cGMP principles and FDA enforcement priorities in 2026
• Common inspection findings and recurring violations
• Strategies for preparing and passing FDA inspections
• Updates on facility requirements, process validation, and documentation
• practices
• Risk-based approaches to ensure ongoing compliance and product quality
• Case studies of cGMP compliance failures and lessons learned
• Best practices for staff training and maintaining a 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.

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.