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.
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.
- Introduction, Purpose, and Objectives
- Defining and Characterizing a Product Lifecycle
Defining The Meaning of Product Quality
The Pharmaceutical Product Lifecycle has been Formalized by ICH Q!0, Pharmaceutical Quality Systems guidance document.
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.
Comparing The Medical Device and Pharmaceutical Lifecycles
- 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
Quality Control across the product lifecycles
Virtual companies/ outsourcing & brick-and-mortar perspectives on the product lifecycle
Why Should you Attend:
- 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
Objectives of the Presentation:
- 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
Who can Benefit:
- 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.
Live Session - How it works
- 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
Recorded Session - How it works
- We will send Username and password 24 hours prior to webinar at your email address.
- Webinar presentation handouts will be shared in pdf format, a day before live presentation.
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- Clear out your queries through interactive Q&A chat boxes with the speaker.
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- Get certification of attendance.
- Once you purchase a webinar you will receive username and password at your email address.
- Use the login details to view recorded webinars.
- 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.