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Featured Articles

August 2012

Agnes Shanley

FDA Fields Tough Questions About Inspections, Challenges Pharma to Be Open, Honest

by Agnes Shanley
Editor in Chief, PharmaManufacturing.com

Last month in Bethesda, at a conference on the Current Challenges of GMPs, presented by Pharma Conference, Inc., FDA officials took FDA's transparency mandate to new levels, by discussing some of the issues they are seeing at pharmaceutical manufacturing and quality operations.

They also addressed some critical questions from industry involving the consistency of field inspections, individual inspector styles, and problems with the review process.

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Cindy Fazzi

Contract Management: What's Compliance Got to Do with it?

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

Contracts are typically the purview of the finance and legal departments. But in regulated environments, the regulatory, quality, and other departments might also be involved in the contract management process.

Depending on the size of a company, the nature of its business, and the regulations and standards it complies with, an organization may be managing different types of contracts, such as quality agreements, supplier agreements, specifications agreement, services contract, IP licensing contracts, nondisclosure contracts, confidentiality agreements, and co-development and co-marketing agreements.

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Ruth Dubinsky

When Good Teams Go Wrong

by Ruth Dubinsky
MS, President, Clarity Consulting

How's your team doing? Are you hitting your targets without leaving "dead bodies" in the wake? Do you sense trust, commitment, and accountability from your fellow team members?

If the answer is yes, fantastic—you're in an elite club! But if your team is like many others, sometimes (or more often than not) you feel "dysfunctional." Not quite working on all cylinders... not cooperating or communicating well... not making decisions that stick. Dealing with power struggles that exhaust and frustrate everyone. Running on empty.

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Did you know that recent studies point to startup funding as being on the decline? "Two studies indicate that funding for U.S.-based startups fell nearly 20 percent in the first quarter of the year, with cautious venture capitalists backing fewer deals."
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