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Submission: On September 16 via api from US — Scanned from DE
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Got it! This website uses cookies to ensure you get the best experience on our website Cookie Consent plugin for the EU cookie law Eventura World * Home * Recordings * Courses * Membership Programs * Answers * Newsroom * Videos * more * Seminar on DI and Part 11 * Seminar on FDA Inspection * * * * * * Eventura World * * * * * * * Home * Recordings * Courses * Membership Programs * Answers * Newsroom * Videos * Seminar on DI and Part 11 * Seminar on FDA Inspection * __ * About us * Contact * Terms & Conditions * F.A.Q's * Legal Disclaimer * Privacy Policy * Documents 1. Home 2. Courses 3. FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies FDA AUDIT PRACTICES AND THE 10 MOST COMMON CITED GMP DEFICIENCIES -------------------------------------------------------------------------------- Sorry, registration has ended. -------------------------------------------------------------------------------- Faculty: Kenneth Christie -------------------------------------------------------------------------------- * Date: 05-03-2021 01:00 PM - 05-03-2021 02:30 PM * Location: Online Event -------------------------------------------------------------------------------- DESCRIPTION A successful audit is dependent on understanding what we could expect from regulators. This can be observed by looking at the focus of recent inspections within the industry. Such case studies will help companies to analyze their own practice and address similar issues in advance. This ensures we will be better prepared for an FDA audit resulting in fewer errors. Furthermore, audit techniques used by the FDA has evolved over the years, anticipating what to expect helps to establish a more focused training program as part of the preparation. This 90 minute online session will focus on the changes in FDA Audit Practices and the current method used to determine audit frequencies by using a system of risk assessments. The word – “AUDIT” creates anxiety for the pharma, biotechnology and medical devices industry. This intensifies if you are unaware of how your company’s practices and procedures compare to the rest of the industry. Understanding the most valid regulations, the audit approaches used by regulators, and the common areas of industry deficiencies are part of getting through a successful regulatory inspection. In addressing all these key elements, this webinar will: * Shed light on better understanding the current FDA Audit Practices and how they have changed over the years * Examine and analyze the top 10 common cited GMP drug manufacturing deficiencies over the last year * Scrutinize the significant increase in the number of warning letters issued over the last years * Review common areas of focus during audits * Provide a template that companies can use to evaluate their own state of compliance * Demonstrate examples to highlight various points discussed Areas Covered in the Session : * Changes in FDA audit approaches * Areas of focus during audits * Most commonly cited drug GMP deficiencies for 2012-2013 * Increase in FDA enforcement actions * Interactive Q&A Session Who Should Attend: * Quality Assurance Teams * Quality Control Teams * Manufacturing Teams * Validation Teams * Production Teams * Regulatory Compliance Teams * Home * Recordings * Courses * About us * Contact * Terms & Conditions * F.A.Q's * Legal Disclaimer * Privacy Policy * Answers * Newsroom * Documents * Videos * Seminar on DI and Part 11 * Seminar on FDA Inspection Subscribe Copyright © 2021 All rights reserved - Eventura World * +1-416-915-4458 * +1-416-915-4438 * info@eventura.world This website uses cookies Okay More info * Tweet * Share * Pin * Mail * Share