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.
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.
Who Will Benefit:
Regulatory Affairs professionals
Quality Assurance professionals
Scientific and Engineering / Product Development Managers
Consultants to any regulated industry
Robert Michalik J.D, RAC, is a Massachusetts regulatory attorney and founder of RegulatoryPro.com, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries. Mr. Michalik has over 25 years’ experience working in the biopharmaceutical and medical device industries.
Compliance4All DBA NetZealous,
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501077LIVE?channel=mailer&camp=Webinar&AdGroup=eventsinamerica_Jan_2017_SEO
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