Description
Seller-provided details for this listing.
Covalent is one of the leading training institutes for Regulatory Affairs in Hyderabad.Course Content of RA is
Introduction to different types of Pharmaceutical products:
Basic concepts on Rx, OTC, API, Starting material, DP/FP,Biologics vs. Biosimilars, Laws vs. Regulations vs. guidelines.
Worldwide regulatory agencies and their role Approval process .
Post-market regulatory obligations GLPs: 21 CFR 58 -The History of GLP, The Idea behind GLP, The Areas of Application, The Pillars of Good Laboratory Practice,
,Indian GLP and International GLP.
CMC topics: GMP, Preformulation studies, ICH Q 7 guideline, 21 CFR 210 and 211, Medical device CE marking and ISO certifications.
Introduction to different types of Pharmaceutical products:
Basic concepts on Rx, OTC, API, Starting material, DP/FP,Biologics vs. Biosimilars, Laws vs. Regulations vs. guidelines.
Worldwide regulatory agencies and their role Approval process .
Post-market regulatory obligations GLPs: 21 CFR 58 -The History of GLP, The Idea behind GLP, The Areas of Application, The Pillars of Good Laboratory Practice,
,Indian GLP and International GLP.
CMC topics: GMP, Preformulation studies, ICH Q 7 guideline, 21 CFR 210 and 211, Medical device CE marking and ISO certifications.