Webinar on FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
Website https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1669 |
Category Medical Devices
Deadline: July 25, 2106 | Date: July 25, 2106
Venue/Country: Online, Canada
Updated: 2016-06-30 18:44:00 (GMT+9)
Call For Papers - CFPThis webinar will look at changes in FDA’s approach to audits and the current method used to determine audit frequencies by using a system of risk assessments.Within the industries of pharma, biotechnology and medical devices, the word ‘audit’ can cause anxiety when you are unaware of how your company’s practices and procedures compare to the rest of the industry. Part of successfully getting through a regulatory audit involves: knowing the applicable regulations, the audit approaches used by regulators, and the common areas of industry deficiencies.In addressing all these key elements, this webinar will:Provide attendees a better understanding of the current audit techniques used by the FDA and how they have changed over the yearsAnalysis of the top 10 most cited GMP drug manufacturing deficiencies over the last yearReview of the significant increase in the number of warning letters issued over the last four yearsReview common areas of focus during auditsProvide a template that companies can use to evaluate their own state of complianceDemonstrate examples to highlight various points discussedPlease Note: This webinar will NOT be available in the Recorded format. This is a LIVE ONLY training.Areas Covered in the Session :Changes in FDA audit approachesAreas of focus during auditsMost commonly cited drug GMP deficiencies for 2012-2013Increase in FDA enforcement actionsInteractive Q&A SessionWho Will Benefit:Quality AssuranceQuality ControlManufacturingValidationProductionRegulatory Compliance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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