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The GMP Letter

You’ve probably wished you had access to the inner workings of the FDA. A trusted friend in the organization with deep insight into FDA’s interpretation and enforcement of cGMPs and quality systems regulation. You’d turn to this person often for valuable information to help you stay in compliance and maintain — or increase — your competitive edge.

The GMP Letter is your go-to resource. GMP has the insights and information you can rely on to ensure your processes, procedures and controls are compliant.

Each month, The GMP Letter’s executive briefings bring you the latest on:

• FDA’s approach to facility inspections such as the agency’s increasing focus on data security
• Changes to the EU’s inspections for MDR compliance
• Joint recognition of GMP inspections in the U.S., EU and other jurisdictions
• Quality regulations and guidances for instance on cybersecurity and data integrity
• And much more…

For the past 30 years, devicemakers who have relied on The GMP Letter have had much-needed information and analysis, enabling them to act swiftly to adjust manufacturing processes.

Bonus! You’ll also receive critical documents including 483s, warning letters, closeout letters, FDA policy notices and more.

Start your one-year subscription (12 issues) to The GMP Letter for only $1,085. You’ll immediately gain access to the latest issue as well as a searchable database of 30 years of past issues.

We’re confident the value GMP provides you will pay for itself many times over. If you disagree, there’s our 100% Money-Back Guarantee.