Slide 1History and Characterization of the A3.01 Cell Line (derived from CEM) and its Tumorigenic and Oncogenic Evaluation September 19, 2012 Vaccines and Related Products…

Slide 1 Slide 2 1 Data Integrity and Fraud – Another Looming Crisis? Edwin Rivera-Martinez, Chief Investigations and Preapproval Compliance Branch Division of Manufacturing…

WHITE PAPER 1  Sonocrystallization Proven Across Scale 1. INTRODUCTION The application of power ultrasound (20 – 100 kHz) to crystallization and chemical processing…

Warehouse In-Plant Training Program At SK+F Eskayef Bangladesh Ltd. Introduction SK+F symbolizes a name-a state of mind. From the inception in 1990, it has today burgeoned…

1 Quality Issues for Clinical Trial Materials: The Chemistry, Manufacturing and Controls (CMC) Review Dorota Matecka, Ph.D. Office of New Drug Quality Assessment, CDER 2…

1. InstantGMP Compliance Seriesfor cGMP Dietary SupplementsFacility Design 2. Facility Design Principles• Design should focus on meeting futureproduction needs• Storage…