Overview: The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based. Most Warning Letters will not have an initial judicial review, resulting in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. A key area gaining attention is a company's suppliers, for both services and products / components. Why needed? FDA expectations? How are successful companies meeting this challenge. Tools that need to be put in place or enhanced. Getting supplier buy-in. Coping with "rogue" suppliers. Areas Covered in the Session:Regulatory "Hot Buttons"Classify suppliersSupplier requirements by "classification"The site audit Types of remote auditsMaintaining the relationshipWho Will Benefit:Senior Management, Project Leaders, Internal / External ConsultantsMid-level management and supervisory personnelCorporate and site coordinatorsRegulatory Affairs Quality systems personnel / QAER&D and engineering staffPurchasing personnelNew product development personnelJohn E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.
26 Jun 2013 @ 10:00 am
26 Jun 2013 @ 11:00 am
Duration: 1 hours
Timezone: GMT -5:00
Organised by GlobalCompliancePanel (deactivated)