ComplianceOnline

Environmental Controls - Simple yet effective improvements to prevent contamination from insects, pests, and dust in controlled areas

Instructor: Jose Mora
Product ID: 700740
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

A cleanroom is intended to protect medical devices from contamination during the stages of their manufacturing process where such contamination is not easily removed or prevented.

Description

This webinar will provide valuable insights to operations managers, supply chain managers, purchasing managers, planners, manufacturing engineers, design engineers, and other operations.

A cleanroom is intended to protect medical devices from contamination during the stages of their manufacturing process where such contamination is not easily removed or prevented. Due to the open environment in which the medical devices are processed and handled, the system must be regularly monitored and maintained to ensure its consistency of effectiveness. There are numerous practical methods for ensuring that the cleanroom environment is designed and maintained to minimize contamination. These involve making areas accessible for cleaning, maintaining a state of control, and other methods.

Areas Covered in the seminar:

  • Definition of Cleanroom and Clean Zones.
  • Controlling the cleanroom's periphery and access points.
  • Cleanroom gowning - selection, cleaning, and control.
  • Equipment and tools inside the cleanroom.
  • Furniture inside the cleanroom.
  • Materials, supplies, and product inside the cleanroom.
  • Maintaining a state of control, and change control.
  • How safety and cleanrooms compliment each other.
  • Use of visual controls to operate and keep cleanrooms clean.

What will students Learn:

  • Cleanrooms vs. controlled environments - what is the distinction?
  • Definition of Cleanroom and Clean Zones.
  • Identifying materials, personnel, gowns, equipment, supplies, utilities, and product destined for cleanroom use.
  • Determining the level of protection, cleaning, and disinfection, where applicable, for each item identified for cleanroom use.
  • Ensuring that all items entering the cleanroom are handled per specified requirements in such a way as to minimize the possibility of contaminating product or the cleanroom’s environment.
  • Maintaining a state of control in the cleanroom and its environment at all times in order to ensure that the cleanroom’s environment is not compromised and that applicable cleanroom standards are upheld.
  • Ensuring that all items leaving the cleanroom to an uncontrolled environment are not returned to the cleanroom without proper processing, cleaning, or protection.

Who will benefit:

This webinar will provide valuable insights to operations managers, supply chain managers, purchasing managers, planners, manufacturing engineers, design engineers, and other operations

  • Project Leaders
  • Functional Managers
  • QA Managers
  • Operations Managers

Instructor Profile:

Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 24 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, Jose 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. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.

Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. Jose worked for 10 years at Cordis Corporation, now a Johnson & Johnson company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

During his time at Cordis, Jose managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support.

Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five Ss (Visual Workplace), process validation to GHSS standards, and similar approaches.

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