Comparing the Pharmaceutical and Medical Device Product Lifecycles

Why Should You Attend:

By understanding the early product lifecycle requirements of medical devices and pharmaceuticals, you will be able to:

• Establish product safety in animals (GLP)
• Establish human safety beginning with the IND& IDE during phase I and phase 2 (Under GMP)
• Establish human safety and efficacy in phases 2 and 3. Increasing GMP)
• Achieve product consistency during validation
• Monitor and maintain product quality in commercialization and post-approval ‘s(Adverse events, complaints, etc.

By learning and understanding the product lifecycle, you will be able to:

• Identify data relationships that predict product and process conditions that can potentially impact product & process quality and consistency
• 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, or 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

Learning Objectives:

• 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

Areas Covered in the Webinar:

1. Introduction, Purpose, and Objectives
2. Defining and Characterizing a Product Lifecycle
1. All product lifecycles have similar elements and cycles but the nature of the product dictates its cycle
2. Major Phases
3. Each phase includes cyclical and noncyclical sequential events
4. Complexity increases as development progresses
5. Events and sequences are active and dynamic during the first product lifecycle
6. Events and sequences may become dormant but events trigger the reemergence
7. 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
1. Some Starting Comparisons Between Medical Device And Pharmaceutical Lifecycles—Introduction, Objectives, Purpose, and Table Of Contents
2. Product Development Phases
3. Regulatory submissions
4. Risk and Risk Management
5. Design Control Requirements
6. Personnel and their qualifications throughout the product lifecycle
7. Equipment design and qualification throughout the product lifecycle
8. Material development throughout the product lifecycle
9. Process development and control throughout the product lifecycle
10. Packaging & labeling throughout the product lifecycle
11. Combining personnel, equipment, materials, and process to develop the master record
12. 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

Who Will Benefit:

This webinar focuses on product lifecycle concepts that are applicable to all of the FDA regulated industries. This session will especially benefit combination products manufacturers because it shows the quality elements, principles and requirements common to all products. The following professionals should attend this training:

• QA
• Regulatory Affairs
• Engineering
• R&D
• Production
• Quality control
• Sales & Marketing

Instructor Profile:

Howard Cooper, has over 35 years experience in the pharmaceutical and medical device industry creating, implementing, managing & remediating quality systems. This experience has shown his leadership, organizing & problem-solving skills to develop quality systems from scratch or in the role of a change agent to remediate failing systems. This experience includes small and large companies operating in the US, Europe and Japan. He has worked with a wide variety of FDA regulated products such as medical devices, in vitro diagnostic reagents and instruments, in vivo diagnostics, pharmaceuticals (Tablets, capsules, injectables), biologicals, monoclonal antibodies), and combination products.

He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

During experience described above, Mr. Cooper has implemented full supplier qualification systems and programs. This includes both consulting and employee roles.

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