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Planning and Developing Quality System Processes for a New FDA Regulated Facility Webinar  

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Seminar Summary:

Learn a practical approach to managing, developing, improving and remediating quality systems, by attending this webinar. (see full course description)

 

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Training Course Syllabus:


Planning and Developing Quality System Processes for a New FDA Regulated Facility Webinar

If you are involved in the developing, manufacturing and marketing of FDA regulated products, regardless of function or experience level, you will learn a practical approach to managing, developing, improving and remediating quality systems, by attending this webinar. If you yourself are starting up a new facility, this webinar will help you gain sufficient insight to prevent major showstoppers, and if you are experiencing FDA scrutiny or quality issues, you will be able to quickly identify the causes for your present circumstances and be able to take action to repair the defective elements.

Areas Covered


  • Quality policy and philosophy

  • "Which comes first - The alligator or the egg" -The Startup Quandary

  • Defining quality and the quality system. Are quality and compliance the same?

  • Factors influencing the framework for the quality system

  • The scope of quality systems in relation to the product lifecycle

  • Quality systems ensure product and user requirements are met

  • An overview of the FDA laws and regulations impacting quality systems. What are the most common elements?

  • Preparation for planning the quality system

  • Senior management competence, leadership, & support are critical for success

  • The competence of the individual employee is the basis for any quality system. Therefore, staffing and training are the key activities

  • Teamwork and coordination between all functions are critical to quality success

  • The quality manual and the technical manuals capture technology, organize functions, cross-functional communications, and preserve the integrity of the system

  • The documentation management system is the basis for design and change control

  • The product design system is like a link in a chain and must be able to support its load

  • Facility design and maintenance

  • Equipment design and qualification calibration and maintenance

  • Supplier and contractor selection, qualification, and control establish the starting base for process building blocks

  • Materials must have specifications and their quality must be controlled and maintained to assure a consistent process

  • Process control starts in design, master records establish process requirements and batch records demonstrate process requirements are met

  • Understanding the role of the quality control laboratory

  • Trial runs, scaling up, and process validation

  • The Pre-Approval Inspection (PAI)

  • Post-Approval

  • Improvement

Why Should you Attend:


  • Less experienced attendees will be able to better understand quality elements and begin to see their interactions form systems and processes

  • More experienced attendees will be able to understand how these systems and processes have inputs and outputs and how to better manage these inputs and outputs in preparation for more responsibilities

  • Experienced attendees will gain insight on designing a new system or improving an existing system

Objectives of the Presentation:


  • The Quality Manual establishes inter-functional communication channels and commitment to work together as a team

  • You have a quality philosophy. Is it positive, neutral, or negative?

  • The quality system has broad boundaries

  • The product lifecycle is integral to the quality system

  • Compliance to regulations must be a major focus but remember they are minimum requirement and do not embody important quality principles and concepts

  • Quality systems must evolve into maturity as a product moves forward in product lifecycle

Seminar Summary:

Learn a practical approach to managing, developing, improving and remediating quality systems, by attending this webinar. (see full course description)

print this agenda print agenda for the Planning and Developing Quality System Processes for a New FDA Regulated Facility Webinar training seminar

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