Design Control, often referred to as product quality planning, has been practiced for many decades. In fact, if you have ever taken part in the review and approval of a technical document, realize that product development occurs through several stages of development with increasing complexity, andhave been involved in the evaluation, testing, and analysis of these lifecycle stages, then you have been involved in and practiced Design Control. Design Control, in simple terms, is a systematic defined sequence of events that occur in the product development and commercialization to ensure that the product meets user requirements.
The ICH Q10 Model defines the pharmaceutical lifecycle as consisting of four phases-product development, technology transfer, commercialization, and product discontinuation.
Within each of these phases, there are defined cyclical and none-cyclical sequential events that must be directed and controlled in order to assure the successful design of products that meet or surpass user requirements.
This webinar is intended to describe and explain these lifecycle phases, including the associated sub-routines. Using graphics, the inputs and outputs of each phase may be seen and studied thus providing a perspective of the relationship of the individual events to the pharmaceutical product lifecycle in its entirety.
Objectives of the Presentation:
To define and explain the inputs and outputs of the design control process that that is inherent throughout the entire product lifecycle.
To demonstrate that design control practices go far beyond compliance dictates adding value to the organization’s employees, products, and processes.
Areas Covered:
Introduction, Overview & Objectives
Defining Quality Systems & Product Quality
Defining Design Control AKA Product Quality Planning
Compliance Requirements for Design Control
Design Space
Risk and Risk Management
The ICH Q10 Pharmaceutical Product Lifecycle
Seeking Product Approval
Phases of the Cycle & Their Gateways
Sub Cyclical and Non-Cyclical Events & Their Gateways
The Role of Regulatory Submissions
The Role of the Quality and Technical Manuals
Roles and Responsibilities of Departmental Functions in Design Control
Active Roles
Supporting Roles
Outsourcing Impacts
Adding Design Control to Your Existing Quality System
Developing and Implementing Design Control in a new Quality System
Who will benefit:
Because all functions have at least some role in the pharmaceutical product lifecycle, the webinar will raise the awareness of the important input factors that influence their functional area.
Particularly beneficial to R&D, Engineering, Production, QA/QC, Maintenance, and IT.
Provide insight to those functions that frequently are involved in supporting product development and improvement such as Purchasing, Accounting, Sales and Marketing and Project Management.
Why you should attend:
By learning and understanding the role of product design throughout the product lifecycle, your company will realize the positive impact that product design has on achieving and maintaining product safety and effectiveness.
By learning and understanding how product design provides a systematic approach that can go beyond compliance requirements resulting in greater customer requirements as well as a more cost-effective product.
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.