eTrainings from PVLMC were created to not only adhere to FDA and ICH regulatory guidance expectations, but also to provide the trainee with an in-depth understanding of best-practice strategies which have been developed and deployed by the CEO of PVLMC.  These strategies have been used to gain approval of many previous biologic products.  Regulations covered by these eTraining courses include but are not limited to the following regulatory guidelines.... •FDA guidance Process Validation: General Principles and Practices, •21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, •21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals, •21 CFR Part 610: General Biological Products Standards, •ICH Q3A: Impurities in New Drug Substances, •ICH Q3B: Impurities in New Drug Products, •ICH Q3C: Residual Solvents, •ICH Q3D: Elemental Impurities, •ICH Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, •ICH Q5C: Quality of Biotechnology Products: Stability Testing of Biotechnological/Biological Products, •ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, •ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, •ICH Q8: Pharmaceutical Development, •ICH Q9: Quality Risk Management, •ICH Q10: Pharmaceutical Quality System, •ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), •ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.