Novatek International Travels to Indonesia November 2012

Novatek International is very proud to announce that Mr. Parsa Famili, CEO and President of Novatek International was the keynote speaker of the Pharmaceuticals Executive Meeting and Discussions in Jakarta, Indonesia. During this meeting scientific processes of Indonesian Pharmaceutical companies and Novatek solutions were discussed. Novatek routinely participate in high level scientific and corporate discussions…

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…

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CDER RELEASES A NEW PET DRAFT GUIDANCE CDER has released as a DRAFT the following Guidance for Industry, “Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography (PET)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.

Effective Cleaning Validation Practices & Critical Cleaning Processes For Pharmaceuticals & Biotech Industries Addressing the most Current Requirements & Practices for Cleaning Validation

IPA – Effective Cleaning Validation Practices & Critical Cleaning Processes for Pharmaceuticals & Biotech Industries Novatek International will be exhibiting its process-based regulatory compliant software solutions at the International Pharmaceutical Academy (IPA) event on Effective Cleaning Validation Practices. The event is to be held October 12-13, 2011 – Montreal, QC. Click the link below for…

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…

TOP 15 BACTERIA REPRESENT 50% OF BACTERIAL ISOLATES IDENTIFIED

ACCUGENIX IDENTIFIED WHAT MICROORGANISMS REPRESENT THE OTHER 50% While having knowledge of the most frequently identified bacteria is informative, it is important to note that these Top 15 bacteria identified from manufacturing environments, as cited in the original post, only represent approximately 50% of the microbes that are identified during routine monitoring and investigations .…

PDA 2011 – Latest Regulatory Requirements for Environmental Monitoring

2011 PDA Annual Meeting San Antonio Texas USA Monday April 11, 2011 Novatek International speaks to Frank S. Kohn, PhD. from FSK Associates Inc. about the latest regulatory requirements for Environmental Monitoring. TRANSCRIPT: “FSK Associates is an international consulting company in the area of contamination control and microbiology, our initials, our theme is really a…