Major CGMP Issues FDA Concerns in 2025
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Speaker : MICHAEL C. REDMOND
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When : Thursday, December 04, 2025
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Time : 01 : 00 PM EST
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Dr. Michael C. Redmond, PhD
Dr. Michael C. Redmond is a globally recognized leader in regulatory compliance and quality assurance. With decades of experience guiding organizations through FDA audits and CGMP implementations, she has built a reputation for translating complex regulatory requirements into clear, actionable strategies. Dr. Redmond draws on practical case studies and her vast industry knowledge to deliver dynamic, engaging sessions that empower participants to build robust compliance frameworks while enhancing operational excellence.
The FDA’s CGMP regulations are critical to ensuring the production of safe, effective, and high-quality goods across various industries. However, as operational environments grow more complex, CGMP violations continue to rise, exposing organizations to significant risks. The year 2025 will see increased regulatory attention on emerging areas like advanced manufacturing, data integrity, and contamination prevention.
This presentation will explore the FDA’s updated guidance and expectations, focusing on major CGMP concerns shaping compliance protocols for 2025. From understanding regulatory trends to implementing best practices, participants will gain essential tools to ensure streamlined processes, avoid FDA enforcement actions, and enhance product quality.
Attendees will also learn about real-world case studies highlighting the consequences of CGMP failures and how organizations can proactively address common pitfalls. Armed with actionable insights, you’ll walk away ready to fortify your quality systems and maintain audit readiness in today’s challenging regulatory landscape.
Areas Covered
- Overview and evolution of CGMP standards regulated by the FDA
- The FDA’s primary CGMP focus areas and enforcement trends in 2025
- Critical updates on data integrity and electronic record management
- Strategies to ensure contamination control in manufacturing environments
- Best practices for process validation and maintaining quality standards
- Risk management techniques to avoid FDA warning letters and recalls
- Real-world examples of CGMP violations and lessons learned
- Tools and frameworks for conducting internal CGMP assessments
- Workforce training and building a culture of compliance within organizations
- Preparing for smoother FDA inspections with enhanced readiness and documentation
Who Should Attend
- Quality Assurance (QA) and Quality Control (QC) Professionals
- Regulatory Affairs Specialists and Managers
- Manufacturing Directors and Supervisors
- Risk and Compliance Managers
- Plant Managers and Production Team Leaders
- Research and Development (R&D) Teams
- Legal and Audit Professionals addressing regulatory risks
Why Should You Attend
- Learn about the FDA’s increased scrutiny on CGMP enforcement and the priorities shaping compliance in 2025.
- Discover the risks of non-compliance, including warning letters, costly product recalls, delayed approvals, and potential legal actions.
- Gain insights into practical strategies for addressing and mitigating CGMP-related issues before they spiral into significant operational risks.
- Understand the updates on data integrity, contamination control, and process validation to maintain FDA compliance.
- FUD liner for marketing purposes: “Are you confident your processes meet the FDA’s increasingly stringent expectations? Stay ahead or face the costly consequences of non-compliance.”
Topic Background
- Overview of Current Good Manufacturing Practices (CGMP) as the foundation for ensuring the safety, efficacy, and quality of FDA-regulated products.
- Explanation of the FDA’s oversight role in monitoring compliance and addressing violations to protect public health.
- Discussion of the industry's challenges in aligning with CGMP requirements amidst evolving technologies and regulatory expectations.
- Focus on new and persistent CGMP issues in 2025, including those affecting pharmaceuticals, biologics, medical devices, and food products.
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$160.00
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