Compliance Trainings, 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
2015-03-19
Description : This webinar is intended to discuss FDA inspection practices and the most common deficiencies for medical device manufacturers including in vitro diagnostic device manufacturers. This presentation is further intended to help you prepare for and manage an FDA inspection in a proactive and effective manner. The top twenty (20) common deficiencies are based on the speaker’s analysis of 483s issued for the past seven (8) years. Areas Covered in the Session : Applicable Laws and Regulation FDA Manuals and Inspection Guides Hosting an FDA Inspection Field Management Directives Inspection Types and Categories Inspection Classification FDA Forms 482 and 483 Top Twenty (20) Most Common Deficiencies During FDA Inspections for Device Manufacturers How to Identify Gaps between FDA Expectations and Firms’ Current Level of Compliance What/How to Prepare for and Manage an FDA Inspection How to Communicate Before, During and After inspection: Dos and Don’ts Common Mistakes and How to Prevent Them How to Most Effectively Use Close Out Meeting Responding to 483s, If Issued How to Communicate with Emotional Intelligence Employee Training Actual FDA Inspection Case Studies (Reports) Speaker’s PASS-IT Suggestions/Recommendations Conclusion Who Will Benefit: Quality Assurance Manufacturing Regulatory Affairs Research & Development Clinical Affairs Senior Management Consultants Contractors Compliance Officers Anyone Interested in the FDA Inspection Price tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
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