'Aseptic processing' diaporamas de présentation

FDA cGMP Training Program

FDA cGMP Training Program. cGMP in the USA Nicholas Buhay Deputy Director Division of Manufacturing & Product Quality Office of Compliance, CDER, FDA. Introduction to Drug. Current Good Manufacturing Practice Of US FDA. An Outline. Legal bases for CGMP CGMP legal principles

615 views • 55 slides

Sterile Drug Process Inspections

743 views • 41 slides

Current Good Manufacturing Practice: Vaccines

Current Good Manufacturing Practice: Vaccines. Mary Malarkey Director, Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research FDA Science Board; April 15, 2005. Summary:Vaccine CGMP. Statutes and regulations Unique challenges with Vaccines

707 views • 33 slides

Regulatory Requirements, Expectations and Hot Topics

Regulatory Requirements, Expectations and Hot Topics. Rachel Blount Global Validation Manager October 2014. Training Objectives. To understand:. The regulatory requirements with regards to cleaning and disinfection The regulatory expectations with regards to cleaning and disinfection

539 views • 29 slides

CPPT 9010: Facility Design & Operation

CPPT 9010: Facility Design & Operation. D.I.T. DT275 Masters in Chemical and Pharmaceutical Process Technology 24 th November 2009 Clement Farrar BA BAI MSc MIEI. Lecture Overview. 1) Introduction 2) Aseptic Processing 3) Process Stages 4) Utilities Introduction

504 views • 28 slides

Facility Design and CGMP Considerations for Cell Therapy Products

Facility Design and CGMP Considerations for Cell Therapy Products. James Crim HHS/FDA/CBER/OCBQ/DMPQ ISCT- 6 th Annual Symposium September 25-27, 2006. SCOPE. Regulatory Overview Current Good Manufacturing Practices (cGMPs) - Expectations During Development Basic facility considerations

550 views • 25 slides

Facility Design and CGMP Considerations for Cell Therapy Products

Facility Design and CGMP Considerations for Cell Therapy Products. James Crim HHS/FDA/CBER/OCBQ/DMPQ ISCT- 6 th Annual Symposium September 25-27, 2006. SCOPE. Regulatory Overview Current Good Manufacturing Practices (cGMPs) - Expectations During Development Basic facility considerations

408 views • 25 slides

Module 3: Aseptic Processing

Module 3: Aseptic Processing. Module 3 Purpose and Objectives. Module Purpose: A short session to discuss how aseptic processing is implemented for lyophilization. Module Objectives: After this module, you will be able to Critique a component implementation with respect to sterility.

785 views • 23 slides

Pharmaceutical Quality Control & current Good Manufacturing Practice

Pharmaceutical Quality Control & current Good Manufacturing Practice. PHT 436 Lecture 5. Good Manufacturing Practices Regulations. Subpart C: Building and Facilities 211.22. Design and construction features Continue. Receiving areas

215 views • 20 slides

Radiopharmaceutical Production

Radiopharmaceutical Production. Filter integrity test. STOP. Filter Integrity Test. The filter integrity test is one of the most important tests that are carried out on the final product.

192 views • 8 slides

Aseptic Processing Market - Global Forecast to 2022

Aseptic Processing Market categorizes the Global Market by Equipment (Processing and Packaging), Application (Bakery & Confectionery, Dairy & Beverages, Poultry, Seafood & Meat, Fruits & Vegetables, and Industrial), Packaging, and Region

124 views • 7 slides

Aseptic Processing Market - Global Forecast to 2022

Aseptic Processing Market by Equipment (Processing and Packaging), Application (Bakery & Confectionery, Dairy & Beverages, Poultry, Seafood & Meat, Convenience Food, Fruits & Vegetables, and Industrial), Packaging, and Region - Global Forecast to 2022

76 views • 7 slides

Aseptic Processing Areas: Facility Classification, Qualification and Routine Monitoring

280 views • 6 slides