Building The Quality System From Scratch Description: The opportunity to establish a new quality system from scratch, according to your own quality philosophy and experience, is challenging yet very rewarding. Imagine, using your influence and knowledge to build the “perfect quality system”. The same principles apply to startup and existing companies. The key to success is to apply quality principles to the existing combination of factors that make up and impact the quality system environment. The same quality principles apply to all of the FDA regulated industries. For compliance purposes, there are regulations for the different industries, such as pharmaceuticals and medical devices. The principals involved in all of these regulations are very common but the differing nature of the products and their processes dictate that different regulations exist to organize compliance functions. The difference between quality and compliance will be explored. This webinar will study the process of building the quality system logistically, chronologically, and how the combination of factors such as process differences, volume, dedicated equipment, product mix, storage requirements, contracts and agreements signed with other companies, and the regulatory environment. An emphasis on structuring the quality system to meet customer and product requirements is emphasized. Why Should you Attend: This will provide considerable insight into how quality systems are constructed and operate to meet customer requirements. If you face the challenge of setting up a new quality system, you will learn how to prevent most if not all of the major showstoppers during preapproval inspection of us facility by the FDA or a client company. If you are not faced with this challenge, you will gain insight about how to actualize product and quality system improvements, and to mitigate quality problems. Objectives of the Presentation: This presentation will begin by emphasizing the commonality of quality principles that are the basis for all medical device and pharmaceutical GMP quality systems. It will discuss the relationship of quality and compliance. He will show how quality system elements work together to assure product customer requirements is met. The presentation is highly graphic to better show the relationships of these elements and the enter functionality required for successful quality system. The discussion of management’s role and responsibilities for quality are well defined. The primary talking points include: o "Which comes first the alligator or the egg" - The Startup Quandary o
An overview of the FDA law and regulations impacting quality systems will be presented
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The scope of quality systems in relation to the product lifecycle
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Quality systems assure product and user requirements are met
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Planning the quality system is a cooperative and shared inter-functional discussion
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Factors influencing the framework for the quality system
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Compliance and quality are not the same-compliance is derived from quality principles. Quality principles have been known and practiced many decades The competence of the individual employee is the basis for quality system. Therefore, staffing and training is the most important activity constantly produces a successful quality system
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The quality manual and the technical manuals capture technology, organize functions, establishes inter-functional communications, and preserves the integrity of the system
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The documentation management system is the basis for design and change control
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The product design system is like a link in a chain and must be able to support its load
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Facility design and maintenance Equipment design and qualification calibration and maintenance
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Supplier and contractor selection, qualification, and control establishes the starting base for process building blocks
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Materials must have specifications and their quality must be controlled and maintained to assure a consistent process
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Process control starts in design and master records establish process requirements and batch records demonstrate process requirements were met
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The importance of in process testing
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Understanding The role of the quality control laboratory Headquarters is coming for a visit
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Trial runs ,Scaling up, and Process Validation
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The Pre-approval Inspection /
Who can Benefit: o Start-up companies o
Any business in the process of constructing or remodeling facilities Quality personnel moving within FDA regulated industries
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Companies with warning letters or consent decrees
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Quality personnel desiring to advance and grow in responsibilities
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Management, Regulatory Affairs, Purchasing, Finance & Cost Accounting
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Project Leaders.
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Thursday, January 24, 2013 10:00 AM PST | 01:00 PM EST Live Session for one participant
Price: $243.00 Corporate Live Session 3 to 4 participants in single location. (For muliple location contact customer care)
Price:$486.00 Corporate Live Session 5 to 10 participants in single location. (For muliple location contact customer care)
Price:$986.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $288.00