By Sandy Weinberg

This booklet publications the reader via FDA law instructions and descriptions a complete technique for expense aid in regulatory affairs and compliance. This booklet explains six recommendations to cost-effectively agree to FDA rules whereas conserving product defense and bettering public entry via expense controls. It presents precious and useful counsel via case stories from pharmaceutical, biotech, and scientific equipment industries.

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If you represent the FDA, you are probably treated with deference tinged with suspicion. In many organizations there is an underlying belligerence—in all, a feeling that a misstep may result in embarrassing legal actions. You are expected to be an expert while the technology is likely to be unique and the applicational area is likely to be tightly focused and obscure. The home office is pressing you to move as rapidly as possible despite a near overwhelming volume of documents, and an attorney and regulatory representative from the company appear ready to pounce if you miss any section or confuse any finding.

Indd 23 2/9/2011 12:24:30 PM 24 CHAPTER 2 CLEAR OPERATION DEFINITIONS OF REQUIREMENTS of control for these situations can result in significant cost savings while maintaining regulatory compliance and product/patient safety. 6 SUMMARY Imagine the role of regulator visiting your pharmaceutical, biologic, or device site. The job is overwhelming. If you are a representative of the EMEA, Japanese Ministry, or other non-US agency, it is likely that English (or at least American English) is not your first language; despite your degree of fluency, you must constantly be on the lookout for subtle nuances of language, unique idioms, and cultural variations in interview, documents, and even casual conversations.

That storm is currently impacting on manufacturing production. Quality by Design is a conceptualization rapidly gaining traction in the biomedical industries, led by an FDA initiative to reduce costs, increase quality control, and shift the primary responsibility for quality assurance firmly onto the industry. While initially focusing on the manufacturing sector, QbD is increasing, being adopted by automated laboratories. In that laboratory setting, where processes focus on sample control, testing, data collection, data analysis, and decision-making, Process Analytical Technology can provide continuous.

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