Experience a profound metamorphosis in U.S. FDA regulations, specifically tailored to supplier cGMP compliance. In this groundbreaking webinar, we delve into the latest FDA initiatives that are reshaping the global medical industry. Companies are now tasked with a comprehensive overhaul of their supply chain management, ensuring stringent adherence to quality standards in the documentation of Certificates of Analysis (COA) and Certificates of Compliance (COC).
These transformative measures hold far-reaching implications for individual compliance objectives, fostering an environment where success is redefined and measured in light of these new paradigms.
The FDA's resolute response to widespread product failures, recalls, and shortages has fueled an urgency for robust oversight throughout the medical product supply chain, both domestically and internationally. As global outsourcing becomes increasingly prevalent, scrutinizing the sourcing of raw materials, components, and services is paramount.
Adding to the complexity are combination products, warranting suppliers to embrace the call for 'better science' and elevate their quality assurance practices to match the heightened expectations. As a result, the FDA's approach to inspections and audits has undergone a substantial shift, setting a novel precedent for companies worldwide.
Witness the paradigm shift wherein 'better science' becomes the new benchmark for COAs and COCs, influencing the documentation landscape. Meanwhile, combination products present a unique set of challenges that demand a proactive approach.
Don't be caught off guard by these groundbreaking alterations. Our high-impact webinar equips you with the necessary knowledge to finesse supplier management and exceed the evolving FDA requirements with unwavering precision.
These transformative measures hold far-reaching implications for individual compliance objectives, fostering an environment where success is redefined and measured in light of these new paradigms.
The FDA's resolute response to widespread product failures, recalls, and shortages has fueled an urgency for robust oversight throughout the medical product supply chain, both domestically and internationally. As global outsourcing becomes increasingly prevalent, scrutinizing the sourcing of raw materials, components, and services is paramount.
Adding to the complexity are combination products, warranting suppliers to embrace the call for 'better science' and elevate their quality assurance practices to match the heightened expectations. As a result, the FDA's approach to inspections and audits has undergone a substantial shift, setting a novel precedent for companies worldwide.
Why Should You Attend:
Stay ahead of the curve with recent developments in FDA regulations, as evidenced by their establishment of dedicated branches in key regions like Mainland China and India, demonstrating the unyielding commitment to enforcing cGMP compliance universally. The onus of compliance falls directly upon the suppliers themselves, as companies can no longer solely delegate this responsibility.Witness the paradigm shift wherein 'better science' becomes the new benchmark for COAs and COCs, influencing the documentation landscape. Meanwhile, combination products present a unique set of challenges that demand a proactive approach.
Don't be caught off guard by these groundbreaking alterations. Our high-impact webinar equips you with the necessary knowledge to finesse supplier management and exceed the evolving FDA requirements with unwavering precision.
Agenda
- The Globalization of the Supply Chain and What That Means
- Combination products and added supplier complexity
- Avoid complacency from past 'good' FDA/ISO audits
- Supplier Trending and Ranking Models
- Mandated Supplier Controls; Change Controls
- COAs/COCs
- Consequences of the 'death' of JIT
- The Tiered Risk-Based Audit Approach
Speaker
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years’ experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new/changed product 510(k)s, process/product/equipment QMS and software validations, ISO 14971 product risk management files/reports, Design Control/Design History Files, Technical Files, CAPA systems and analysis.He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis/management, FDA/GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.
