1 / 2

Webinar On Good Practices in Preparing for an FDA Inspection

This webinar is intended to help you get familiar with how to prepare for and get ready for an FDA inspection.

compliancetrainings
Download Presentation

Webinar On Good Practices in Preparing for an FDA Inspection

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. ContactUs:416-915-4458 WeEmpower,YouComply! Good Practices in Preparing for an FDA Inspection Preparation with Awareness: Do's and Don'ts Product Id FDB1350 Category Food, Drugs & Biologics Scheduled On Monday, June 16, 2014 at 13:00 Hrs Duration 60 Minutes Speaker Dr. David Lim Toregisterforthiswebinarhttps://compliancetrainings.com/siteengine/Login.aspx Webinar Description: This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection in an actionable, sustainable manner with improved awareness. If a firm is subject to FDA regulations, they should be ready for an FDA inspection. This webinar provides “PASS-IT” strategy and strategic plan/planning on your FDA inspection preparation integrated with emotional intelligence (EQ) skills. It is delivered in a way to help you effectively communicate and improve awareness and preparedness for an FDA inspection at all levels of organizations. This webinar will discuss what you need to be aware and familiar with to get ready for an FDA inspection with confidence. In particular, a list of Dos and Don’ts will be shared and explained for your maximum advantages. Areas Covered in the Session: • Applicable Statutes and Regulations • Definitions • FDA Manuals • FDA Inspection: Scope and Depth • Inspection Types and Categories • Inspection Classification • Inspection Process • Hosting an FDA Inspection • Act with Awareness and Familiarity • Common Questions and Responding to Questions • FDA Forms 482 and 483 • Responding to 483:  How to Avoid Mistakes • Before, During and After FDA Inspection: Dos and Don’ts

  2. Who Will Benefit: • CEOs • VPs • Compliance Officers • Attorneys • Regulatory Affairs • Clinical Affairs • Quality Assurance • Research & Development Teams • Consultants • Contractors/Subcontractors • Anyone Interested in the FDA inspection Process SpeakerProfile: Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com). Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. For more visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1350

More Related