Weinberg, Sandy,  1950- <br/><br/>
Cost-contained regulatory compliance  for the pharmaceutical, biologics, and medical device industries /  [electronic resource] : 
Sandy Weinberg. 
 - Hoboken, N.J. :  John Wiley & Sons,  c2011. 
 - ix, 284 p. :  ill. 
<br/><br/>Includes bibliographical references and index. 
<br/><br/>Controlling regulatory costs -- Clear operation definitions of requirements -- Pre-regulatory audits -- Quality by design -- Outsourcing -- Electronic submissions -- Emea/fda coordination -- Managing FDA inspections -- Risk assessment -- Cases -- Cost containment analysis -- Managing regulation in times of chaos -- International regulation -- Cost contained regulatory compliance. 
<br/><br/><br/>Electronic reproduction. <br/>Palo Alto, Calif. : <br/>ebrary, <br/>2011. <br/>Available via World Wide Web. <br/>Access may be limited to ebrary affiliated libraries. 
<br/><br/><label>ISBN: </label>
<br/><br/><label>LCCN: </label>
<br/><br/><label>Subjects--Corporate Names: </label><br/>United States. Food and Drug Administration. 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Medical instruments and apparatus industry--Cost control.--United States<br/>Medical instruments and apparatus--Inspection--United States.<br/>Pharmaceutical industry--Cost control.--United States<br/>Pharmaceutical industry--Inspection--United States.
<br/><br/><label>Index Terms--Genre/Form: </label><br/>Electronic books.
<br/><br/><label>LC Class. No.: </label>HD9994.U52  / W45 2011eb 
<br/><br/><label>Dewey Class. No.: </label>615.1068/1