'Container closure system' presentation slideshows

INTRODUCTION TO ICH Q8 & Q9 GUIDELINES

INTRODUCTION TO ICH Q8 & Q9 GUIDELINES. K. S. BABU Head - Corporate Regulatory Affairs Watson Pharma., India November 29, 2007. FOREWORD. EMPHASIS Interpretation of guidance documents Regulatory relevance & applications Bonus: Q10 guideline, due to its relevance.

1.27k views • 51 slides

API Stability

API Stability. Lynda Paleshnuik. Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009. Overview. Stress Testing Selection of Batches Container Closure System Specifications Testing Frequency Storage Conditions Stability Commitment. Overview.

1.03k views • 46 slides

1.04k views • 30 slides

OGD Perspectives

GPhA Fall Technical Conference. OGD Perspectives. Gary J. Buehler, R.Ph. Director, Office of Generic Drugs October 26, 2005. Topics. Productivity Operations Issues New Endeavors Positive Progress Industry Contribution. Office of Generic Drugs. Operations Issues. Hiring.

786 views • 28 slides

OGD Perspectives

GPhA Fall Technical Conference. OGD Perspectives. Gary J. Buehler, R.Ph. Director, Office of Generic Drugs October 26, 2005. Topics. Productivity Operations Issues New Endeavors Positive Progress Industry Contribution. Office of Generic Drugs. Operations Issues. Hiring.

378 views • 28 slides

Assessing Quality-by-Design A CMC Review Perspective

494 views • 28 slides

Pharmaceutical Development with Focus on Paediatric Formulations

650 views • 26 slides

DEPARTMENT OF HEALTH Medicines Regulatory Affairs (Pharmaceutical & Related Product Regulation & Management)

DEPARTMENT OF HEALTH Medicines Regulatory Affairs (Pharmaceutical & Related Product Regulation & Management) EDMS Workflow Specification and Software Configuration Project Update E Taute SAPRAA 21 Nov 2008. EDMS Workflow & Configuration Project. EDMS Workflow & Configuration Project.

450 views • 16 slides