FDA Expectations: Overcoming Supply Chain Weaknesses

FDA expectations of supplier management will continue to evolve as pressures are applied to the agency, device recalls are issued and outsourcing continues to expand. To ensure that quality is maintained, it’s important to understand where weaknesses are often found.

How to Respond to FDA Inspection Observations, Even Those You Dispute

Martin Browning from EduQuest provides insight on responding to Form 483 observations: "It’s critical to show FDA that you are in control of the situation and are attempting to comply voluntarily by doing everything possible and reasonable to ensure that your products meet Agency specifications."

Can You Trust E-Signatures From Your Software Package Vendor?

Martin Browning from EduQuest provides insight into the validity of e-signatures from vendors: "Validation must include documentation, or it is not validation. At a minimum, you must establish (note the regulatory meaning of that word) the validity of the e-signatures you want to accept based on your intended use."

Making Smarter Product Recall Decisions: 4 Critical Steps to Meeting FDA’s Expectations

FDA’s multi-layered rules for product recalls can resemble a double-edged sword. Have you under-reported your recall? Over-reported? How can you find middle ground and ensure compliance? Martin Browning proposes a 4-step decision process.

The View from Washington: What Device Makers Need to Know about FDA’s Latest Strategic Priorities and Initiatives

Continuously hammered by Congress, news media and the international health community, the U.S. FDA has responded with a five-year plan that could have far-reaching consequences for the medical device industry.

How Often Should You Audit Your Suppliers?

EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, the experts offer Supplier Auditing insight.