'Process validation' presentation slideshows

FDA API Inspections

FDA API Inspections. Robert C. Horan, PhD FDA Pharmaceutical Inspectorate New York District. Quality System observations. FDA 483 Observations for Product Quality Reviews range from : No SOP for Product Quality Reviews No Product Quality Reviews conducted

1.22k views • 92 slides

Quality Assessment and the Assessment Report

Quality Assessment and the Assessment Report. Lynda Paleshnuik. Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.

796 views • 57 slides

SAPRAA March 2013

919 views • 53 slides

WHO workshop on Quality, good manufacturing practice and bioequivalence with a focus on antituberculotics Jiaxing, China

WHO workshop on Quality, good manufacturing practice and bioequivalence with a focus on antituberculotics Jiaxing, China 5 to 9 November 2007. Finished Pharmaceutical Products (FPPs). Theo Dekker, D.Sc. Research Institute for Industrial Pharmacy

674 views • 51 slides

Chapter 21

Chapter 21. Critical Systems Validation. Critical Systems Validation. Validating the reliability, safety and security of computer-based systems. Validation perspectives. Reliability validation Does the measured reliability of the system meet its specification?

765 views • 51 slides

Dr. Steffen Gross Section Mono-/Polyclonal Antibodies Paul-Ehrlich-Institut Germany pei.de

892 views • 49 slides

Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Tallinn 15-19th October 2007

Pharmaceutical Development. Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Tallinn 15-19th October 2007. Pharmaceutical Development. Pharmaceutical Development of Finished Pharmaceutical Products (FPPs) Presenter: Susan Walters

474 views • 47 slides

Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Tallinn 15-19th October 2007

Pharmaceutical Development. Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Tallinn 15-19th October 2007. Pharmaceutical Development. Pharmaceutical Development of Finished Pharmaceutical Products (FPPs) Presenter: Susan Walters

665 views • 47 slides

WHO Training Workshop on Pharmaceutical Quality, G MP and Bioequivalence with a focus on artemisinines

648 views • 46 slides

MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS

MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS. Module 5. Presented by : Deryck Smith Consulting Engineers. GMP Manufacturing Environments. Air Handling Systems HVAC Systems H eating V entilation A ir C onditioning Module 5: Validation, Qualification

779 views • 43 slides

PROCESS VALIDATION OF OINTMENT/CREAM FORMULATION

A SEMINAR ON. PROCESS VALIDATION OF OINTMENT/CREAM FORMULATION. Why need of process validation for ointment/cream?. Product bio burden high? Multiple component? More adequate preservative system? All have Newtonian flow behavior? History : Zinc oxide rash cream that was heated

5.11k views • 40 slides

Current Good Tissue Practice (CGTP) Draft Guidance

Current Good Tissue Practice (CGTP) Draft Guidance. Martha Wells, MPH Division of Human Tissues OCTGT, CBER, FDA March 30, 2009 AATB Spring Meeting, Orlando FL. To Discuss Today. Regulatory basis - CGTP Scope of draft guidance

1.17k views • 36 slides

Energy Simulation Tools for Buildings

Energy Simulation Tools for Buildings. Philip Haves Lawrence Berkeley National Laboratory phaves@lbl.gov. Presentation Outline. Applications and motivations History High level architecture Physical phenomena Levels of modeling detail and approximations

422 views • 30 slides

http://www.fda.gov/cder/guidance/6672dft.pdf

http://www.fda.gov/cder/guidance/6672dft.pdf. Objectives. Describe the common vision. Product quality and performance achieved and assured by design of effective and efficient manufacturing processes

389 views • 28 slides

Structure of Dossier of Medicinal Product- Q part

Structure of Dossier of Medicinal Product- Q part. Gabriel K. Kaddu Head, Drug Assessment and Registration National Drug Authority.

734 views • 23 slides

TANGA AIDS WORKING GROUP (TAWG ) Indigenous knowledge Program Presented at the World Bank, Washington DC 11 th July 20

TANGA AIDS WORKING GROUP (TAWG ) Indigenous knowledge Program Presented at the World Bank, Washington DC 11 th July 2005. PRESENTER: Dr. S. Mtullu PROJECT MANAGER TANGA AIDS WORKING GROUP (TAWG) P.O. BOX 1374, TANGA-TANZANIA

421 views • 21 slides

Manufacturing Process

Manufacturing Process. Rutendo Kuwana Technical Officer, WHO, Geneva. Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.

662 views • 20 slides

Radiopharmaceutical Production

Radiopharmaceutical Production. QC Tests Chemical Purity. STOP. Chemical Purity.

256 views • 16 slides

FEDIAF Guide to Good practice

FEDIAF Guide to Good practice. for the Manufacture of Safe Pet Food TRAINING PACKAGE Module VIII Production. 8. PRODUCTION TOPICS. 8.1 General requirements 8.2 Presence of genetically modified organism 8.3 Feed materials of animal origin 8.4 Weighing 8.5 Mixing

218 views • 11 slides

Introduction

DEVELOPMENT, OPTIMIZATION AND PROCESS VALIDATION OF THE MODIFIED QUASSI EMULSION SOLVENT DIFFUSION METHOD FOR THE PREPARATION OF MICROSPONGES Rishabh Srivastava *, Kamla Pathak Department of Pharmaceutics, Rajiv Academy for Pharmacy, Mathura, Uttar Pradesh- 281001. Introduction.

476 views • 11 slides