4-Hour Virtual Seminar on Combination Product Supplier Management: Stay Ahead of the Curve with Recent Developments in FDA Regulations

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Nov 17, 2023, 17:45 ET

DUBLIN, Nov. 17, 2023 /PRNewswire/ -- The "4-Hour Virtual Seminar on Combination Product Supplier Management" webinar has been added to ResearchAndMarkets.com's offering.

Join our groundbreaking webinar to explore the latest FDA initiatives reshaping the global medical industry. Companies are facing the challenge of revamping their supply chain management to ensure strict adherence to quality standards when documenting Certificates of Analysis (COA) and Certificates of Compliance (COC).

These transformative measures have significant implications for compliance objectives, requiring a reevaluation of success in light of these new paradigms. The FDA's response to product failures, recalls, and shortages has created an urgent need for robust oversight in the medical product supply chain, both domestically and internationally.

As global outsourcing becomes more prevalent, scrutinizing the sourcing of raw materials, components, and services is essential. Additionally, combination products present new complexities, requiring suppliers to embrace 'better science' and elevate their quality assurance practices to meet heightened expectations.

The FDA's approach to inspections and audits has shifted significantly, establishing a new precedent for companies worldwide. Don't miss this opportunity to gain insights into the evolving regulatory landscape and ensure compliance with the latest FDA initiatives. Join us to stay ahead in the changing world of medical product supply chain management.

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.

Key Topics Covered:

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

For more information about this webinar visit https://www.researchandmarkets.com/r/y81als

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SOURCE Research and Markets