Chemistry 101 for Medical Device Regulatory & Quality Professionals: Essential knowledge needed to Manage Drug&Device Combination Product Project webinar at fremont 2017

OVERVIEW:
Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect.

 

In this webinar, you will learn the basics of small molecule and larger molecule (protein chemistry) development and testing. Once a foundation is laid, the discussion will shift to "real world" practical considerations that you must be aware of to spot problems, obstacles that will arise in every product development program.

Product Id : 501077
Instructor : Robert Michalik

Why should you Attend:
Most regulatory, quality and R&D professionals rise within an organization due to their scientific and technical understanding of the products in their company’s pipeline. For design engineers working in the medical device industry, the knowledge they need to support more complex drug/device combination products is lacking. For those who wish to gain insights into the key parameters that define compliance with CMC regulation and drug chemistry, this webinar will provide that knowledge.

Areas Covered in the Session:

• Chemistry 101: A review of the basics
• Molecular structure and its impact on drug activity (smaller molecules behave differently from larger molecules)
• Techniques commonly used in drug synthesis, manufacturing and quality control testing.
• CMC Regulatory Compliance: Brief but comprehensive review of the essetials
• How to spot a CMC-related problem and what to do when you suspect one.
• Case studies that illustrate common issues that arise relating to drug components in combination device products
• FAQs and Essential follow-up reading for those who want more resources

Who Will Benefit:

• Regulatory Affairs professionals
• Quality Assurance professionals
• Marketing professionals
• Scientific and Engineering / Product Development Managers
• Consultants to any regulated industry

IMPORTANT DATE:

Webinar Date: Wednesday, January 25, 2017 | 10:00 AM PST | 01:00 PM EST

Duration: 90 Minutes

Others Details

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