Novatek International Travels to Israel

Novatek International is very proud to announce that Mr. Richard Sasseville, Associate Director of Product Innovations was part of a delegation that met with Dr. Jeremy M. Levin, DPhil, MB, BChir, President and CEO of TEVA Pharmaceuticals in Israel recently.   During this meeting scientific processes of TEVA and Novatek solutions were discussed. Novatek routinely participate…

Novatek International contributes again in the latest PDA publication, “Environmental Monitoring” Volume 6

Novatek International is very proud to once again announce that Ms. Susan Cleary, Associate Directors of R&D and Mr. Parsa Famili, President and CEO at Novatek International have contributed to the recent PDA publication: Environmental Monitoring, Volume 6, edited by Jeanne Moldenhauer, chapter 16 “Automation of Environmental Monitoring; Achieving Efficiency and Control”, 2012. This series…

PDA/FDA Joint Regulatory Conference – Booth 21

September 10-12 – Baltimore, MD Novatek International will be exhibiting its process-based LIMS software solutions such as Quality Management Systems, Stability Program Management, Environmental Monitoring & Utility Monitoring, Calibration & Preventive Maintenance, and, Automated Packaging Component Proof Reader at the 2012 PDA FDA Joint Regulatory Conference in Baltimore, MD USA. Come visit us at Booth…

MEDIA FILLS FOR VALIDATION OF ASEPTIC PREPARATIONS FOR POSITRON EMISSION TOMOGRAPHY (PET) DRUGS

CDER RELEASES A NEW PET DRAFT GUIDANCE CDER has released as a DRAFT the following Guidance for Industry, “Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography (PET) Drugs.  The Comment period will be 90 days. Please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273766.pdf to obtain this DRAFT document.

610.12 CBER PROPOSED STERILITY TESTS

PART 610.12 — CBER GENERAL BIOLOGICAL PRODUCTS STANDARDS PROPOSED   Enclosed is the summary of the proposed requirements for the revised CBER 610.12 Sterility Test. For additional information, please see below for a summary or visit the enclosed web site for the full release http://www.gpo.gov/fdsys/pkg/FR-2011-06-21/pdf/2011-15346.pdf The authority citation for 21 CFR part 610 continues to read…

Challenges and Successes in Implementing an Electronic Environmental Monitoring Data Management Solution

From September 12 to 13, 2011, Basel, Switzerland It is with great pleasure that Susan Cleary, B.C.S, M.B.A., Associate Director of Product Development at Novatek International will be speaking at this year’s Europe GBPR, Inc. event on Challenges & Successes in Implementing an Electronic Environmental Monitoring Data Management Solution September 12 to 13, 2011 in…