Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents an

Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

Maintaining their Quality Management System (QMS) processes in a state of control, by way of controlled documents and objective evidence, and documenting them in the form of records, is a core requirement for all life science businesses.

In addition, an additional responsibility that life science manufacturing plants have is giving the assurance that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions. They should also ensure that evidence of this work is maintained by controlled records.

In the pre-computer systems and databases era, managers and quality personnel created complex visual numbering systems and separate files for purposes of retrieval and control. Over the years, this system evolved into the extremely complex and convoluted systems that are prevalent today throughout the life sciences industry.

Although automation technology has brought in changes at this level, this has yet to completely replace the legacy policies and rules that were necessary with manual and paper systems but are now obsolete.

The problem is that, all but only a handful of life science companies have outgrown the old manual habit. Their insistence on retaining legacy policy has been preventing them from reaping the full benefits of automation and information retrieval systems.

A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show how to approach document systems using the theory of Lean Documents and its upshot-the Theory of Lean Configuration.

José Mora, a senior professional in the medical devices industry, who is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems, will be the expert at this session.

Please log on to Compliance4all to register for this session.

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This learning is for those who have been constantly struggling at creating, managing, and maintaining all of the information found in controlled documents. Apart from being redundant and repetitive, most of this is usually bunched together in a rather haphazard manner. By attending this webinar, participants will gain a different perspective and a very sensible approach that they can put to proper use and organize their controlled documents. The result is that there is no confusion or disorderliness in maintaining and presenting crucial documents. It will help them save on the enormous resources that unorganized maintenance of controlled documentation consumes. José Mora will present a new approach to documentation that is based on solid principles and proven practices.

This webinar will benefit Managers, Supervisors, Directors, and Vice-Presidents in the areas of R&D, Manufacturing Engineering, Design Assurance, Quality Assurance, Operations and Document Control.

José will cover the following areas at this webinar:

• Brief introduction to Lean Documents and Lean Configuration
• Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
• Basic functions found in a life sciences manufacturing plant
• Key types of controlled documents and records for manufacturing
• Quality Management System (QMS) elements controlled via documentation
• Bringing it all together.

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About the speaker:

José Mora, a Principal Consultant specializing in Manufacturing Engineering and Quality Systems, has worked in the medical device industry specializing in manufacturing, process development, tooling, and Quality Systems for over 30 years. 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.

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

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.