Comparing the Pharmaceutical and Medical Device Lifecycles

Duration: 150 Minutes
This webinar will explain the workings of the product lifecycle for pharmaceuticals and medical devices. Although the goal of product lifecycle is to yield a product meeting user and customer requirements, the product lifecycle differs between pharmaceuticals and medical devices because of the nature the products and their intended use.
Product Life Cycle
Instructor: Howard T Cooper
Product ID: 500187
Quality and compliance requirements are coordinated in a multi-functional matrix with competing objectives. Senior management must be involved in these activities and use data and their persuasive skills to readily “step in and make adjustments” to achieve and maintain customer satisfaction. Customer satisfaction ensures the continuance of the organization and is the best friend of management.
  1. Introduction, Purpose, and Objectives
  2. Defining and Characterizing a Product Lifecycle
    • All product lifecycles have similar elements and cycles but the nature of the product dictates its cycle
    • Major Phases
    • Each phase includes cyclical and noncyclical sequential events
    • Complexity increases as development progresses
    • Events and sequences are active and dynamic during the first product lifecycle
    • Events and sequences may become dormant but events trigger the reemergence
    • Regulations significantly impact the product lifecycle
  3. Defining The Meaning of Product Quality
  4. The Pharmaceutical Product Lifecycle has been Formalized by ICH Q!0, Pharmaceutical Quality Systems guidance document.
  5. The Medical Device Product Lifecycle was formalized by the now defunct GHTF in late 2011 ------ The New International Medical Device Regulatory Forum (IMDRF) is expected to continue defining the device life cycle.
  6. Comparing The Medical Device and Pharmaceutical Lifecycles
    • Some Starting Comparisons Between Medical Device And Pharmaceutical Lifecycles—Introduction, Objectives, Purpose, and Table Of Contents
    • Product Development Phases
    • Regulatory submissions
    • Risk and Risk Management
    • Design Control Requirements
    • Personnel and their qualifications throughout the product lifecycle
    • Equipment design and qualification throughout the product lifecycle
    • Material development throughout the product lifecycle
    • Process development and control throughout the product lifecycle
    • Packaging & labeling throughout the product lifecycle
    • Combining personnel, equipment, materials, and process to develop the master record
    • Monitoring product quality throughout the product lifecycle
  7. Quality Control across the product lifecycles
  8. Virtual companies/ outsourcing & brick-and-mortar perspectives on the product lifecycle
  9. Additional Thoughts
  10. Review
Why Should you Attend:
  • By learning and understanding the product lifecycle, you will be able to:
    • Identify data relationships that impact product quality
    • Identify locations that are the source of root cause failures in order to expedite investigations
    • Identify opportunities for product and process improvement
    • Build project management templates that help drive product development
  • If your company is implementing a quality system, seeking opportunities for improvement, are in need of implementing regulatory body compliance requirements, this webinar will provide you with:
    • An overview of the logical flow of processes along with their inputs and outputs in order to modify or write procedures that meet compliance requirements
    • A better understanding of the roles and responsibilities of cross-functional task and responsibilities and how they relate to your functional roles and responsibilities
  • If you have combination products, this webinar will:
    • Demonstrate that there are more similarities than differences in establishing quality and compliance control points
    • Show how quality systems of devices and drugs may be mixed and matched to meet compliance requirements are
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 product lifecycle concepts 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
  • QA, Regulatory Affairs, Engineering, R&D, Production, and quality control
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  • Get certification of attendance.
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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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Live Session - How it works
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  • 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 https://www.onlinecompliancepanel.com/login
  • 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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