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Being prepared for QA/compliance audits | 1915
Journal of Developing Drugs

Journal of Developing Drugs
Open Access

ISSN: 2329-6631

+44 1478 350008

Being prepared for QA/compliance audits


2nd International Summit on GMP, GCP & Quality Control

November 12-14, 2013 DoubleTree by Hilton Hotel Chicago-North Shore, IL, USA

Kristin Kelley

Accepted Abstracts: J Develop Drugs

Abstract :

Read the audit plan or agenda and challenge standards that do not apply in advance of the audit. Be sure you understand the purpose and scope of the audit. Make a brief but thorough opening presentation and provide a handout to the auditor(s). Prepare the staff for the visit. Assemble all required documentation in advance. Inform the auditor(s) in advance of the visit about any expectations and restrictions. ? You may not take photographs ? You will need to cover your hair and clothing during the tour of ? You may request photocopies of Assure that compliance with applicable standards is demonstrated with clear and concise documentation. ? Be prepared to address missing and/or ambiguous documentation ? Log any copies that auditors are given to keep ? Provide as much as you can in advance What to do when the findings are presented.

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