Compliance4All, Online
2017-01-25
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.
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 Marketing professionals Scientific and Engineering / Product Development Managers Consultants to any regulated industry
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