Compliance Notes - BioPharm International

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Compliance Notes

Quality Agreements for Contract Manufacturers

September 1, 2014

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

Operational Excellence: More Than Just Process Improvement

October 1, 2013

By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.

State of Quality and Compliance in the Biopharmaceutical Industry

April 1, 2013

Have FDA initiatives improved manufacturing quality?

Connecting QbD, Knowledge Management, and Supplier Quality Management

November 1, 2012

Understanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost.

Reduce Analytical Testing and Costs Without Compromising Compliance

July 1, 2012

Unnecessary analytical testing can lead to unnecessary costs.

Know the Regulations

June 1, 2012

The contract provider needs to know as much as the NDA holder.

How to Respond to Consent Decrees

May 1, 2012

How to handle and respond to a consent decree.

Preparing for an FDA Inspection in a Global Pharmaceutical Environment

April 1, 2012

FDA has created a dedicated cadre of foreign drug investigators and established permanent offices worldwide.

Putting Risk-Based Decision-Making Where It Belongs

March 1, 2012

Focusing on how risk affects the entire organization can improve the business bottom line.

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