'Good manufacturing practice' diaporamas de présentation

REVISION OF EUDRALEX VOL. 4 - GMP Luisa Stoppa, Ph.D. Inspection and Certification Department Italian Medicines Agency

3.84k views • 115 slides

Non-Clinical Drug Development

Non-Clinical Drug Development. Chris H. Takimoto, MD, PhD Institute for Drug Development San Antonio Cancer Institute University of Texas Health Science Center San Antonio, TX. Drug Development. Drug discovery & screening Non-clinical development Animal scale up Phase I studies

2.38k views • 81 slides

Good practices of food chain in Polish food industry facts and chalanges

Good practices of food chain in Polish food industry facts and chalanges. Ma?gorzata Korzeniowska Wroc?aw University of Environmental and Life Sciences. Life Cycle Assessment. Definition of food chain

1.95k views • 63 slides

Human/animal use considerations

Human/animal use considerations. Protection of Human Subjects. Basic principles Clinical trials should be conducted in accordance with generally accepted ethical principles

707 views • 58 slides

GOOD MANUFACTURING PRACTICE

2.39k views • 38 slides

Non-Tariff Measures

Non-Tariff Measures. Willy Tinner State secretariat for economic affairs. What are Non-Tariff Measures (NTM)?. Other than duties: Standards and procedures SPS TBT Customs procedures Security measures (9/11) Etc. Non-tariff measures more and more important as tariff barriers fall.

722 views • 35 slides

Non-Tariff Measures

Non-Tariff Measures. Willy Tinner State secretariat for economic affairs. What are Non-Tariff Measures (NTM)?. Other than duties: Standards and procedures SPS TBT Customs procedures Security measures (9/11) Etc. Non-tariff measures more and more important as tariff barriers fall.

603 views • 35 slides

Non-Tariff Measures

Non-Tariff Measures. Willy Tinner State secretariat for economic affairs. What are Non-Tariff Measures (NTM)?. Other than duties: Standards and procedures SPS TBT Customs procedures Security measures (9/11) Etc. Non-tariff measures more and more important as tariff barriers fall.

945 views • 35 slides

Bovine Spongiform Encepalopathy, BSE

Bovine Spongiform Encepalopathy, BSE. Should FAO have maintained its silence?. Why did FAO sound the alert?. Active surveillance for BSE introduced by some infected countries indicated higher rates of infection than previously thought

777 views • 35 slides

Monitoring the Product

Monitoring the Product. Production, Import, Wholesale and Retail Level Monitoring. Different Levels of Monitoring The Product: Iodized Salt. At production facilities At import sites At wholesale depots At retail shops. For Each Level:. What information is needed?

459 views • 32 slides

Supplementary Training Modules on Good Manufacturing Practice

Validation Part 4: QC-related validation. Supplementary Training Modules on Good Manufacturing Practice. Validation. Introduction Why is analytical monitoring necessary? What is the purpose of analytical validation?. Validation. Objectives To introduce the concepts of :

635 views • 28 slides

Supplementary Training Modules on Good Manufacturing Practice

Validation Part 4: QC-related validation. Supplementary Training Modules on Good Manufacturing Practice. Validation. Introduction Why is analytical monitoring necessary? What is the purpose of analytical validation?. Validation. Objectives To introduce the concepts of :

772 views • 28 slides

473 views • 25 slides

Making products available for medical abortion and strategies for their introduction

Making products available for medical abortion and strategies for their introduction. Peter Hall Acting CEO Concept Foundation Bangkok, Thailand. The mission of Concept Foundation. To provide access to products for sexual and reproductive health of assured quality

601 views • 21 slides

WHO Training Workshop on Pharmaceutical Quality, Good Manufacturing Practice & Bioequivalence Quality of BE Studies

WHO Training Workshop on Pharmaceutical Quality, Good Manufacturing Practice & Bioequivalence Quality of BE Studies Kiev, October 3-7, 2005 Dr. H. Potthast (h.potthast@bfarm.de). Regulations. ICH-GCP guideline (CPMP/ICH/135/95) Guide to GMP incl. Annex 13 WHO documents

283 views • 18 slides

Supplementary Training Modules on Good Manufacturing Practice

459 views • 15 slides

Validation Part 5: Review and summary

Supplementary Training Modules on Good Manufacturing Practice. Validation Part 5: Review and summary. Validation. Objectives To review: WHO validation definition Philosophy of validation Personnel requirements Protocol requirements DQ IQ OQ and PQ summary Checklist for validation.

997 views • 13 slides

ESH & Q

ESH & Q. DOE-NP Annual S&T Review of Radionuclide Research & Production (RR&P) J. Bullis November 19-20, 2009. Summary of RR&P Facility Characteristics. 2 Buildings 1 Accelerator Facility (BLIP) Not normally occupied An accelerator facility covered by SAD/ASE ( November 2009)

145 views • 13 slides

329 views • 10 slides

Prescription Drug Importation Public Meeting April 14, 2004

Prescription Drug Importation Public Meeting April 14, 2004. Jim Rittenburg Authentix 610 861 6965 www.authentix.com. Drug Importation. Drug counterfeiting is a recognized global problem Incidence of fake drugs in US has been low due to FDA oversight

344 views • 9 slides