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…Details
Novatek International speaks to: Amy Davis, Davis Healthcare International Publishing, LLC President and Adrienne Fierro, Vice President of Marketing PDA at the 2012 PDA Annual in Phoenix Arizona. TRANSCRIPT: Ilona: “Congratulations on your new book, Environmental Monitoring Volume 6. If you an tell us a little bit about it and when it will be released.”…Details
Novatek International speaks to Mike Parkes, COO of RCA Regulatory Compliance Associates at the 2012 PDA Annual in Phoenix Arizona. TRANSCRIPT: Cheryl: “We are at PDA annual at Phoneix Arizona. It is an honor and a pleasure to be standing here with Mike Parkes. He is the COO of RCA.” What I wanted to ask…Details
The Environmental Monitoring Data Management & Trending System Software – The Industry Standard It seems like just yesterday, when the Pharmaceutical Microbiology Forum Newsletter – March 2004, Vol. 11 (1) was published. One of the hot topics at the time was Environmental Monitoring (EM) and the question of the day was: How many people are…Details
April 16-18, 2012 – Phoenix, AZ Novatek International will be exhibiting its process-based LIMS software solutions at the 2012 PDA Annual Meeting: Manufacturing Innovation: Achieving Excellence in Sterileand Emerging Biopharmaceutical Technology, April 16-18, 2012 in Phoenix, AZ USA Come visit us at Booth #512 for a live demonstration. For more detail follow this link: 2012…Details
Featuring a Summary of Ben Venue Issues
Policy changes and enforcement strategies implemented by the FDA have led to an increase in the number of inspection of both Contract Manufacturing Operations (CMOs) and in-house sterile manufacturers — especially injectables. There has been a greater oversight and detailed review of all protocols and processes. Any issue or potential issue must have a corrective action with a demonstrated positive outcome. There no longer exists a prescribed sequence of events after a Form FDA 483 is issued. Contract Manufacturing Operations, in particular, must now have strategies to ensure GMP compliance at their facilities involved in “arms length” activities with innovator and generic firms and be prepared for more frequent and thorough audits.Details
March 12-15, 2012 – Orlando, FL
Novatek International will be exhibiting its process-based LIMS software solutions at the Pittcon Conference & Expo from March 11-15, 2012 in Orlando, FL USA. Come visit us at Booth #1884 for a live demonstration.
For more details follow this link:
Pittcon Conference & Expo
Biomedical Engineering: Healthcare Systems, Technology & Techniques Chapter 1 Submission by Novatek International
Novatek International is very proud to announce that Mr. Aram Montazami, Vice president of R&D at Novatek International has contributed to the recent Springer publication: Biomedical Engineering: Health Care Systems, Technology and Technique. The Biomedical Engineering series is an edited volume with contributions from world experts. It provides readers with unique contributions related to current…Details
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.
Join Novatek International at Booth # 12 at PDA’s 6th Annual Global Conference on Pharmaceutical Microbiology October 17-18: “Challenges Facing Pharmaceutical Microbiology in the 21st Century” at Bethesda North Marriott Hotel and Conference Center, Bethesda, Maryland USA.