Managing Supply Chain Risks: Meeting FDA Expectations is the management report that will help you select, audit and monitor outsourcing partners to ensure quality problems are contained and harmful products don’t reach patients.

The FDA already has considerable authority to enforce its quality regulations up and down the supply chain. But in the past, it has lacked the resources. In the last six months, that has started to change with increased funding for inspections. And next year, it's likely to change even more as Congress puts together new laws designed to enhance enforcement activities and reach deeper into the supply chain to ferret out potential problems.

To get ahead of the enforcement curve, you need to get a handle on your suppliers and identify and fix the weak spots in your supply chain today.

To clean up your supply chain, get expert advice from author Martin Browning, president and co-founder of EduQuest, Inc., and a global team of FDA compliance experts. Mr. Browning has more than 30 years of regulatory experience, including 22 years at the FDA and in his current role as a highly sought-after advisor to industry.

Mr. Browning’s career at the FDA included:

• Work in the field offices as an investigator and as a senior manager in the Office of Regulatory Affairs at FDA headquarters
• Serving as a special assistant to the Associate Commissioner for Regulatory Affairs
• Chairing the U.S. government’s ISO 9000 committee
• Sitting on the FDA committee that developed the medical device quality system regulation

Place your order today and learn how to:

• Establish procedures to adequately review outsourcing partners before you sign a contract that creates unchecked liability
• Carefully assess processes to determine whether outsourcing makes sense, including making sure you do not outsource one of three key types of processes that should never be handed off to a third party
• Put in place monitoring and auditing programs that will satisfy the FDA's quality requirements
• Negotiate contracts that provide adequate oversight and accountability on the part of your vendors

Mr. Browning helps clients solve problems related to FDA regulation, quality assurance, compliance auditing and software and systems engineering, including the assessment of vendors and outsourced operations. Now, he’s ready to help you in this management report — a must-read for employees of drug and device manufacturers, as well as their suppliers, including:

• QA/QC personnel
• Regulatory affairs professionals
• Compliance officers
• Consultants/service providers
• Managers
• Manufacturing directors and supervisors
• Risk management specialists

Buy Now!
Get all the insights from a former FDA insider with Managing Supply Chain Risks: Meeting FDA Expectations. Just $397 and available to you today in print or PDF format.