From FDA 483 Findings to Digital Manufacturing Readiness

Sponsored
Learning Level: Intermediate
Time: 1000 - 1100 ET 
Session Length: 1 hour

FDA Form 483 observations and warning letters provide valuable insight into the operational, quality, and data-management challenges facing pharmaceutical manufacturers today.

Many recurring findings point to broader issues such as incomplete production records, use of paper printouts, limited process visibility, data integrity risks, disconnected systems, and inefficient review processes. As manufacturers advance their digitalisation efforts, connected manufacturing equipment, including intelligent checkweighing systems and automated completeness checks, is playing an increasingly important role in improving manufacturing readiness and the move towards digital transformation.

In this webinar, regulatory expert Bob McDowall and industry specialists from METTLER TOLEDO will explore how FDA observations can be translated into practical opportunities for improvement. Using connected checkweighing systems and automated completeness checks as real-world examples, the session will demonstrate how manufacturers can improve traceability, data quality, process visibility, and review readiness.

Learning Objective

By the end of this webinar, participants will be able to:

  • Interpret common FDA 483 observations in the context of broader manufacturing, process-control, and data-integrity challenges.
  • Identify practical opportunities to improve traceability, record review, process visibility, and data quality through connected manufacturing systems.
  • Evaluate how automated completeness checking, connected equipment, and standardized production data can support digital manufacturing readiness, compliance, and operational improvement.

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Speakers

Dirk Bettels
Senior Product Manager
Mettler-Toledo Garvens GmbH
Robert McDowall, PhD
Director
R D McDowall Limited
Frank Borrmann
Market Manager
Mettler Toledo