Online Training 2015 - Coordinating The Design and Implementation of the Quality System With the Pharmaceutical Product Lifecycle - By Compliance Global Inc

Overview:
The use Of Product Lifecycle Management (PLCM) has been practiced for a considerable length of time but it is only in recent years has there been a rising consciousness of the benefits of using the knowledge of product lifecycle to deliver products successfully in this highly regulated, competitive and demanding pharmaceutical and medical device marketplace. Knowledge applied to technology delivers “super products” that can perform ultimate diagnosis and treatments. The problem is delivering a cost effective product that balances the needs of the medical profession with the resources available to make the delivery. Regulatory requirements coupled with pressure to reduce cost increases this challenge. Not to mention the impact of combination products. Call Quality.
Quality can be that driving force that uses quality principles to balance the needs and requirements of all customers. Quality, according to Juran is “the totality of features and characteristics of a product or service that barrel the ability to satisfy stated or implied needs”. This is followed by his definition of the quality assurance system as “the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management”. Finally, he describes the quality loop as “the conceptual model of interacting activities that influence the quality of the product or service in the various stages ranging from identification of needs to the assessment of whether these needs have been satisfied.” This loop is the product lifecycle.
The emphasis is not on the “quality show” but is on the “quality team” that incorporates all functions. The term “Quality Team” means a quality approach and qualified/competent staff. Quality works with senior management to guide interdepartmental communications that focus on collaboration in the understanding of each function’s requirements. Objective persuasion and discussion through multi- functional review and approval process makes it happen. Senior Management is the final “referee” who objectively makes key decisions. Senior management wins if it can lead a competent and cooperative team. Senior Management loses if it attempts to lead an incompetent and/or arbitrary team. Senior management is in control of the business as well their destiny. They are accountable.
The GHTF (IMDRF) Product Lifecycle “(PLC) starts with “Product development process” followed by ”Product Realisation” and “Placing on the Market” completing the development, pre-approval, and pre-market steps. After approval, it moves to the “Product Use” or commercialization. “End of Product Life” ”follows “Product Use”. Finally, it reaches the last stage, “Destruction, Disposal, Manufacture, and “Reuse of Parts”. Medical device GMP, Part 820, was first promulgated in 1978 at the same time of the last major revision of the pharmaceutical GMP’s. However the 1978 medical device GMP departed from the strict regulatory compliance tone to more emphasis on quality including a risk-based approach. This 1978 GMP regulation evolved into the revised Part 820, The Quality System Regulation. This revision was in no doubt a quality systems approach as evidenced by “ISO-like features”. The other medical device standard/regulation is ISO 13485. Similarities and differences exist between Part 820 & ISO 13485.
Why Should You Attend:
Gain insight and knowledge about the design and operation of the medical device quality system in order to plan and develop a new system or revamp existing system
Identify ways to make quality improvements
Areas Covered in this Webinar:
This webinar will focus primarily on Part 820 but will incorporate quality principles and focus on satisfying customer requirements. The webinar will show how the quality system evolves starting with a new company and a new product to developing new products for approval & marketing.
Where is our company at this moment in time
Defining quality, quality system, and customer requirements
Introduction to Juran’s Quality Loop and its relationship to the product lifecycle
Cycling through the GHTF (IMDRF) product lifecycle
Boundaries, Scope, and Major Elements of Medical Device Quality Systems
Major factors that impact the planning and structure of the Medical Device Quality System
The Quality Manual
Product Concept- R&D Quality System, GLP, Design Control-GHTF (IMDRF) references
Product Realisation- GLP, Design Control-GHTF (IMDRF) references, 510K, PMA, GCP, EPA
Placing on the Market- GLP, Design Control ?GHTF (IMDRF) references, 510K, PMA, GCP
Product Use - GMP/GXP, Product Improvement
End of Product Life - GXP
“Destruction, Disposal, Manufacture, and “Reuse of Parts”. GXP, EPA
Discussion of full-page handouts in graphical format
This webinar will make considerable use of graphics to explain the quality concepts and will also include full-page PDF handouts explaining the concepts.
Learning Objectives:
Provide knowledge, based on experience, about the basics for establishing a new medical device quality system for a new medical device company
How to revamp an existing medical device quality system
Who Will Benefit:
Important Note: While this webinar focuses on quality principles, is intended for all interdepartmental functions that work with quality related matters. Consider the following:
Senior Management
Research and Development Professionals
Engineering and Design Professionals
Sales and Marketing Professionals
Accounting & Finance Professionals
Regulatory Affairs Personnel
Supply Chain Professionals
Level:
Beginner
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