Medical Devices Compliance
Validation of Trace – Level Analyses for Impurities and Degradation Products
Low-level compound analysis has many differences from that of the more common analyses aimed at major components. The requirements for accuracy and precision are different. Selectivity to differentiate very similar compounds, such as isomers of the various types – substituent positional, optical, alkyl are some – becomes critical since these may differ in toxic effects.
- To learn how to have a structured approach to minor component identifications that are the acceptable
- Understanding the validation and documentation needs for the different approaches
- The use of libraries versus manual data interpretation
- Using the interconnection between data
- Completing the cycle – checking that an identification is correct
- On-going strategies
I have extensive experience in developing new analytical chemistry methods in chromatography and spectroscopy.in environmental analysis; characterization of petroleum and its refined products, petrochemicals, polymers, and other materials, GLP protocols for compliance with Food and Drug Administration Good Laboratory Practices for newly developed drugs.
I also work in the area of career development for scientists, with a focus on coaching better supervisory skills and team building.
Specialties: Method development; method validation; coaching
With a FREE membership you can get one Exclusive Video every 30 days!
With a free memebrship account, you can browse the entire library, buy credits & attend live webinars and read expert posts. Join and explore the coolest complaince platform ever. Feel free to upgrade anytime to view all Exclusive content and get additional benefits for your account.
Do I have to pay to join?
For FREE signups there is no payment required. No Credit Card needed. We also offer EDGE & PRO, paid memberships.
What are the different formats?
There are Live and Recorded, Expert led webinars. Durations vary from 30min to 6hrs. Standards & checklists are in pdf form
What if I am interested in more than one exclusive?
You can upgrade to EDGE memebrship at any time and enjoy unlimited Exclusive viewing. All our memebrships are annual plans.
How many videos can I watch?
As a FREE memebr you get 1 free exclusive video every 30days. You can buy additional videos.
Who are the Experts?
All Experts on our platform are handpicked or referred by other Experts based on years of experience & proven expertise in providing learning & consulting advice.
What if I have questions after watching a video?
We provide first of its kind, Expert on Call service, where you can directly schedule one on one call with the Expert of your choice & discuss.