2018 - Through the Eyes of an Auditor

Description :
Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally, an auditor has personal experiences of what a state of control looks like and has visited sufficient places to know what to look for.
Anyone in a medical device setting must be prepared for an audit at any and all times. This webinar provides insight into the kinds of clues an auditor might use in determining what areas to focus on. It isn´t intended to cover all regulations and standards. What it does cover is the general mental checklist that will influence how well an audit goes, as well as the culture and environment a company´s management must encourage so that impression is a good to excellent one.
Areas Covered in the Session :
• What the auditor is looking for and why
• The first five minutes
• Touring the plant and manufacturing area
• Entering and touring the warehouse
• Entering and touring a cleanroom
• Entering and touring lab areas
• Reviewing documents
• Reviewing the quality system
• Summary
Who Will Benefit:
• Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
• R&D
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Operations
• Document Control
About Speaker:
José Mora is a Principal Consultant and Project Manager specializing in Manufacturing Engineering, Quality Systems, and Lean Transformations. José is a recognized subject matter expert in process validation, lean manufacturing, lean controlled document systems, startup operations, process development and quality systems,
Venue: Online
Speaker Name: Jose Mora
Price : $ 239
Tuesday October 16 , 2018
EST 13:00
Duration : 90 Minutes
Tel: +1-844-216-5230
Email:support-AT-compliancetrainingpanel.com
https://www.compliancetrainingpanel.com/Webinar/To...