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Through the Eyes of an Auditor

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Website https://worldcomplianceseminars.com/webinardetails/455 | Edit Freely

Category

Deadline: July 25, 2018 | Date: July 25, 2018

Venue/Country: Online, U.S.A

Updated: 2018-07-11 13:47:18 (GMT+9)

Call For Papers - CFP

Through the Eyes of an Auditor

Time: 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

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.

Why should you attend:

An experienced auditor does not need to dig very far - he or she already has a mental checklist. You need to know what that is.

The importance of housekeeping, proper maintenance, ordeliness, and following safety rules.

The importance of visual indicators - and following them.

Utility rooms and custodial closets are often places to hide clutter. Some experienced auditors know that this tells them more about your systems than the clean and presentable areas.

How using the same logic as the auditors can help you be in a state of constant readiness.

Areas Covered

1. What the auditor is looking for and why

2. The first five minutes

3. Touring the plant and manufacturing area

4. Entering and touring the warehouse

5. Entering and touring a cleanroom

6. Entering and touring lab areas

7. Reviewing documents

8. Reviewing the quality system

9. Summary

• And much, much more…

Who will Benefit

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

• R&D

• Manufacturing Engineering

• Design Assurance

• Quality Assurance

• Operations

• Document Control

Speaker Profile

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.

Price: $199 One Dial-in One Attendee | Corporate Live Recorded $249 One Dial In - Max 10 attendees |Group $399 Multiple locations upto 5 dial in | Recorded $249


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.