Vimal Sachdeva

Company: WHO

Job title: Technical Officer (Senior GMP Inspector)

Seminars:

GMP Inspection Excellence for Highly Potent API Manufacturing 9:05 am

– Introduction to WHO Prequalification Programme (PQP) and inspections of pharmaceutical manufacturers for WHO PQP – WHO Guidelines used for inspection of highly potent or hazardous substance – Newly adopted points to consider documenting for manufacturers and inspectors on environmental aspects – Frequent challenges for the industry; how do these challenges differ for inspection in…Read more

day: Day Two

Panel Discussion: Manufacturing Quality, Operator Safety & Regulatory Considerations in Sterile HPAPI Production 9:35 am

• Is the application of negative (HPAPI) or positive (Sterile) pressure cascades most appropriate? • Design of engineering controls for sterile production and reduced cross contamination for quality assurance • Revisions to Annex 1 and surrounding regulatory landscape • Measuring product quality and operator safety in sterile HPAPI manufacturingRead more

day: Day Two