Designing And Implementing The Quality System From Scratch

Duration: 90 Minutes
The opportunity to establish a new quality system from scratch has three potential results. The most rewarding is a cross-functional systems approach that balances quality activities to achieve product performance requirements and meeting internal and external customer requirements (needs & wants). The least desired outcome is a failed quality system that is so dysfunctional that it threatens the organization’s very existence.
Building a New Quality System
Instructor: Howard T Cooper
Product ID: 500065
The final result is a quality system operating between the extremes of the above-described outcomes. It is known as mediocrity. This webinar will focus on the quality system that delivers results and is very self-actualizing. It is based on the need for achieving basic quality elements and then building on these elements to achieve the self-actualizing quality system.

Many factors influence the robustness of the quality system. Some of these influences involve our own philosophy of life and quality. Senior Management must be the driving power that recognizes the power of quality principles to achieve organizational excellence. Senior Management can show this commitment in several ways. The most important is to provide resources to meet the needs of the organization. Management must understand and care about the role of the quality system in meeting corporate objectives. It must perceive the role of the quality function in the same way that it understands other functions such as R&D, Sales and Marketing, Finance and other organizational functions. They must understand the company’s mission and publish quality policy that communicates “I am a role model for quality”.

All FDA quality systems strive to achieve quality using dedicated (i.e. pharmaceutical, device, GMP.GLP, GCP) quality systems that contain essentially the same elements. It is the understanding of how these elements work together to produce a quality system that is essential to a successful quality system.

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.

The primary talking points are:
  • 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 law 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 the quality system. Therefore, staffing and training are a key activity.
  • Teamwork and cooperation 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 and master records establish process requirements and batch records demonstrate process requirements were met
  • Understanding role of the quality control laboratory
  • Headquarters is coming for a visit.
  • Trial runs, Scaling up, and Process Validation
  • The Pre-Approval Inspection (PAI)
Why Should you Attend:
This presentation 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:
  • Provide insight for the planning, developing, and implementation of quality systems
  • Discuss success factors
  • Define the quality system based on the product and quality process lifecycles
  • Describe the intricate planning process
  • Provide a roadmap that organizes the task and their sequence in designing and building process
  • Describe how continuous product and process improvement increase organizational efficiency and effectiveness
  • Demonstrate the commonality of all quality systems
  • Provide insight to expedite the development and implementation of the quality system.
Who can Benefit:
  • Start-up companies
  • Any business in the process of constructing or remodeling facilities
  • Quality personnel moving between FDA regulated industries
  • Companies with warning letters or consent decrees
  • Quality personnel desiring to advance and grow in responsibilities
  • Management, Regulatory Affairs, Purchasing, Finance & Cost Accounting
  • Project Leaders
  • Research and Development
  • Leaders and Managers Responsible for Managing and That regulatory functions such as Environmental Pollution Agency (EPA), Drug Enforcement Agency (DEA).
Recorded Session - How it works
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  • Presentation handouts will also be shared in pdf format.
  • Access to the recording is valid only till 6 months starting from the date of purchase.
  • Get certification of attendance.
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Recorded Session for one participant
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  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Howard T Cooper has over 40 years’ experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which provided a very advanced and preventative approach toward quality systems. He quickly advanced to a managerial role experiencing responsibilities for quality management, quality system mitigation, and startup of new breweries. After leaving the brewing industry, he joined a medical device contractor when the Medical Device Amendments were being finalized. His first challenge was to establish a GMP system that met the needs of the large medical device clients that contracted with the company to produced finished medical devices. This very successful challenge led him to focus on startup quality systems and to mitigate failing quality systems.

His experience includes:
  • Designing and implementing Quality Systems from scratch in several startup operations.
  • Managing both single and multiple site quality operations
  • Assisted in revamping failing quality systems under warning letters and consent decrees
  • Advised large FDA regulated companies to improve their quality operations.

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