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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE SPECIFICATIONS:…

Documents ICH Q6A Guideline

1.12 ICH Q6A Guideline Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Comments for its application ICH Q6A C 101 Specifications:…

Documents Microbiological Validation Mark Oldcorne Wrexham Maelor Hospital.

Slide 1Microbiological Validation Mark Oldcorne Wrexham Maelor Hospital Slide 2 What is Validation? The QA of any preparation activity is reliant on the satisfactory validation…

Documents medical devices and invitro diagnosis by rahul sagar, m. pharm(dra), bbau lucknow

1. A Presentation On Validation of Medical Devices 5/5/2015 1 2. Rahul Sagar M. Pharm IInd sem Pharmceutics- DRA PRESENTED BY 2 5/5/2015 3. Contents  Medical devices and…

Documents ICH Topic Q 6 A

European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: [email protected] http://www.emea.eu.int…

Technology Streamlining Testing with Visual Studio 2012

1. Streamline Testing withVisual Studio 2012Imaginet Resources Corp.http://www.imaginet.com 2. Agenda• Software Quality Assurance Practices• Opportunities to Streamline…

Documents L EGAL I NTERPRETING B ASICS Carla M. Mathers, Esquire, SC: L A MARIE Center presentation.

Slide 1 L EGAL I NTERPRETING B ASICS Carla M. Mathers, Esquire, SC: L A MARIE Center presentation Slide 2 S TARTING POINT : DEFINITIONS Community Interpreting Legal Interpreting…

Documents Quality Unit Roles and Responsibilities. Overview Directive Statement and Scope Glossary...

Slide 1 Quality Unit Roles and Responsibilities Slide 2 Overview Directive Statement and Scope Glossary Responsibilities The Requirements What cannot be delegated  Typical…

Documents Low Res Courier 5i SL and Courier 6

7/16/2019 Low Res Courier 5i SL and Courier 6 1/12Courier 5i SL and Courier 6i SLState-of-the-art technologyCourier SL analyzer systems oer unrivalledsensitivity and the…