The opportunity to design a total quality management 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".
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.
Why Should You Attend
For those facing the challenge of developing a quality system, this webinar provides very valuable insights and practical advice that 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
Areas Covered in this Webinar
I.Introduction, purpose, and objectives
II.Defining the status quo. Where am I right now and where do I want to go
Who & where
What has to be done & and when does it have to be done
How can it be accomplished
III.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
IV.The Employee - competent, qualified, dedicated, & trained for advancement
V. Planning & developing the quality assurance 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
VI.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
VII.Understanding and planning facility and equipment requirements based on the facility and equipment lifecycle and manufacturing cycle
VIII.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
IX.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
X.Maintaining and improving the quality system - the economics of quality systems
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 Will Benefit
All FDA Approved Industries
Combination Products Manufacturers
Constructing or remodeling Facilities
Companies with Warning Letters or Consent Decrees
Management, Regulatory Affairs, Purchasing, Finance & Cost Accounting Professionals
Research and Development Professionals
Regulatory Leaders and Managers
Howard Cooper has over 40 years of experience facing the challenges of managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which exposed him to an advanced and preventative approach toward quality. He then took this experience to the medical device industry when the medical device amendments of 1976 were being written and promulgated. He quickly distinguished himself as a change agent and a forward thinking quality leader.
Mr. Cooper built on this experience to set up a pharmaceutical /medical device and combination product quality system. Since that time, he has worked with incubators, small companies, and large international corporations in the quality and regulatory affairs. In 2004, he became an independent consultant continuing his work to manage, develop, and implement quality. Mr. Cooper particularly enjoys sharing his experience with others to further develop them for successfully running quality operations.