'Critical quality attributes' presentation slideshows

Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations

QUALITY BY DESIGN. Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Mumbai, India Date: May 2008. QUALITY BY DESIGN. Dr Tom Sam President Industrial Pharmacy Section International Pharmaceutical Federation (FIP). QUALITY BY DESIGN. products.

482 views • 41 slides

Submission and Review of Preparation Process Dossiers

Submission and Review of Preparation Process Dossiers. Overview. When to submit a PPD Overview of Submission Procedure Overview of Review Procedure Questions. PPD Submission. When to submit a PPD. New process New licence including processing Change i n processing

444 views • 33 slides

446 views • 31 slides

Quality Assurance in Pharmaceuticals and Challenges it faces in 21 st Century

Quality Assurance in Pharmaceuticals and Challenges it faces in 21 st Century. By: Muhammad Naeem Quality Assurance and Regulatory Manager CCL Pharmaceuticals (Pvt.) Ltd. Quality Assurance.

380 views • 30 slides

Risk-Based CMC Review

862 views • 29 slides

CTD Documents as Key Reviewer Tools

CTD Documents as Key Reviewer Tools. Michelle Herrera Foster, Ph.D. Senior Regulatory Consultant. Objectives. Explore how Common Technical Document (CTD) documents can serve as key reviewer tools, to meet the needs of the agency reviewers and internal reviewers

399 views • 23 slides

Introduction to PPDs Regulatory requirements and rationale

Introduction to PPDs Regulatory requirements and rationale. Overview. Background to the HTA and its regulatory remit Introduction to Preparation Process Dossiers (PPDs) European Union Tissues and Cells Directives (EUTCD)

320 views • 18 slides