QMS FOR MEDICAL DEVICES HANDLING, MEDICAL DEVICES 2016 - Medical Devices: Handling, Storage, Distribution, and Installation - By Compliance Global Inc

Website https://complianceglobal.us/product/700478/SusanneManz/medical%20devices-handling-storage-%20distrib | Edit Freely

Category Education; E-Learning

Deadline: July 26, 2016 | Date: July 26, 2016

Venue/Country: Online Webinar, U.S.A

Updated: 2016-06-30 14:22:26 (GMT+9)

Call For Papers - CFP

Medical devices handling, medical devices storage, medical devices distribution, and medical devices installation procedures need to be established for all medical devices manufacturers. These procedures define and control how devices are handled, stored, distributed, and installed with customers. The objectives of these regulations are to ensure the quality of in-process and finished devices is not compromised and to ensure there are no product mix-ups, damage, deterioration, or contamination.

The processes and controls for release of product through the various stages within production, into finished inventory, through market distribution all need to be defined, with clear control points which prevent release and use of product which has not completed all required manufacturing and test stages.

Distribution records should be maintained which record what devices were shipped, when they were shipped, and wherethey were shipped to and also record any necessary identification and traceability identifiers.

If there are environmental requirements for the device in storage and in transit, then these need to be defined and controls established to ensure such environmental requirements are continually achieved.

Where a device has specific installation requirements, the requirements need to be documented and processes established and monitored to ensure correct installation.

Why Should You Attend:

Handling, Storage, Distribution, and Installation are often forgotten and neglected parts of the Quality Management System (QMS) for medical device companies. But, failure to fully establish these processes in your company can still have a serious impact on your company and on your customers.

Failures can negatively impact your business in terms of manufacturing efficiencies, your inventory levels, scrap, yields, and more. Even more importantly, failures can lead to customer delays, dis-satisfaction, complaints, quality problems, and more. This webinar will help you avoid these costly and painful problems.

Areas Covered in this Webinar:

Handling processes

Preventing Mix-ups, damage, deterioration, contamination

Storage requirements including stock rotation

Environmental controls

Authorizing receipt and dispatch from storage areas

When a product’s fitness for use / quality deteriorate over time

Identification of products

Installation procedures including inspection and testing

Important linkages to other QMS requirements

Learning Objectives:

Overview of the Regulations

FDA Expectations

Lessons Learned and Common Mistakes

Best Practices

Preparing for FDA Inspections

Who Will Benefit:

QMS Auditors

Quality Engineers

Manufacturing Engineers

Field Service and Installation Engineers

Manufacturing Supervisors

Manufacturing/ Production /Operations/ Distribution Supervisors, Managers, and Directors

Plant Managers

Quality Managers

Employees new to Medical Device Companies

For more information, please visit : https://complianceglobal.us/product/700478/SusanneManz/medical%20devices-handling-storage-%20distribution-and-%20installation/1

Email: supportcomplianceglobal.us

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515

Level:

Intermediate

Speaker Profile:

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.

Susanne has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality.

Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.