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Chemistry 101 for Medical Device Regulatory webinar by Compliance4all

Start Date:
Wednesday, 25 January, 2017
End Date:
Wednesday, 25 January, 2017 11:30am
Health & Nutrition

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 Speaker Profile:Robert Michalik J.D, RAC, is a Massachusetts regulatory attorney and founder of, 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.


161 Mission Falls Lane,
Suite 216

Organizer Details

Conference organized by Compliance4ALL

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

161 Mission Falls Lane, Suite 216

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