Developing the Quality System from Scratch

Duration: 150 Minutes
The opportunity to design a quality system from scratch offers great rewards in experiencing and understanding the functions of quality systems. For me, this "dream" of building the "perfect quality system" began during my early quality management days as I learned and experienced quality system successes and failures. I learned from these thinking and dreaming, "If only I could set up my own quality system".
Quality system development
Instructor: Howard T Cooper
Product ID: 500180
Finally, this dream came true when I was given the opportunity to design and implement a combination pharmaceutical and medical device quality system from scratch. Since this first experience, I have designed and implemented several quality systems (including virtual) that have resulted in successful preapproval inspections. I have also revamped failing quality systems to make them more compliant and effective.

As you can imagine, starting from scratch and revamping failing systems is hard work, but the experience and knowledge gained is extremely valuable. The relationships built, both positive and negative, will last forever. I want to share these experiences with you so that you may gain insight about the hard work, expectations, pitfalls, and the rewards of starting a system from scratch.
  1. Introduction, Purpose, and Objectives
  2. Defining the status quo. Where am I right now and where do I want to go
    • Why
    • Who & Where
    • What has to be done & and when does it have to be done
    • How can it be accomplished
  3. Defining the Scope Of the Quality System And Planning
    • Why have a quality system?
    • Quality systems operate throughout the lifecycle of the company and its products
    • Many factors influence the development of the quality system
    • Beware! Quality and Compliance are not equal and never will be
    • Project Management is the way to go but the role of the team members must be well-defined, understood, and competence plays a major role in success
  4. The Employee-Competent, Qualified, Dedicated, & Trained For Advancement
  5. Planning & Developing the Quality Manual requires multi-functional involvement and dedication and, most important, the conscious effort to a commitment of working together for the good of the organization
    • Senior Management takes a leadership role in developing and establishing the quality system
    • Quality Manual Characteristics
    • Quality Manual Contents
    • Establishing priorities for determining the order for planning, developing, and implementing quality system procedures
    • Using modern word processing, databases, graphics to simplify and expedite completing the quality manual
    • Change Control as it applies to the quality manual
  6. The Technical Manual captures the technology and technical requirements and may be considered as a separate entity or as part of the quality manual
    • Defining technical documentation starts with product concept and continues throughout the product lifecycle-at the start of the lifecycle is called design and later is called change control and they are synonymous
    • Design may be defined as a development of technical documentation that defines it establishes requirements
    • Change control as it applies to the technical manual and technology
  7. Understanding and planning facility and equipment requirements based on the facility and equipment lifecycle and manufacturing cycle
  8. Materials Must Meet Requirements so That the Facility and Equipment Has the Capability to Produce Consistent and Predictable Products
    • Qualifying the Material and the Supplier or Contractor
    • Maintaining Material Quality
  9. Developing The Master Record begins in product development and culminates at the end of design at which time it represents the "HOW" for manufacturing the product with consistent and predictable quality that meets customer requirements
  10. Maintaining and improving the quality system
  11. The Economics Of Quality Systems
Why Should you Attend:
  • For those facing the challenge of developing a quality system, this webinar provides very valuable insights and practical advice you can be applied to their quality system development
  • For those with existing quality systems, this webinar provides insights and information that may be used to improve or remediate your quality system.
Objectives of the Presentation:
  • To provide an overview of all the factors and nuances that influence the development of the quality system
  • To provide insight so that a person or organization can gain a perspective on their current situation in order to begin planning for developing and implementing a quality system
  • To provide some very practical methods and ways to design and develop and implement a more effective quality system
  • To provide examples from the many years of experience the speaker has in designing, developing, and implementing quality systems from the ground floor.
Who can Benefit:
  • This webinar focuses on quality system principles that are applicable to all of the FDA regulated industries
  • Particularly applicable to combination products manufacture because it shows the quality elements, principles and requirements common to all products
  • 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).
Live 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.
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • 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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