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June 2017

IVT 5th Annual Microbiology Week

June 14, 2017 @ 8:00 am - June 16, 2017 @ 5:00 pm
Wyndham Philadelphia Historic District, 400 Arch Street
Philadelphia, 19106 United States

Join Novatek at the IVT 5th Annual Microbiology week!  We will be both exhibiting and speaking at this year's event. Novatek Presentation: Risk Based Environmental Monitoring (EM) and EM Data Management and Trending Presentation Series Speakers: Ms. Marsha (Hardiman) Steed, Senior Consultant, Concordia Valsource & Mike O'Grady, Director Marketing, Novatek International Key Learnings: How to perform an Environmental Monitoring risk assessment unique to your manufacturing process Recent changes in guidance documents and regulations for EM Programs including contamination control rates,…

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IVT Stability Testing Europe

June 20, 2017 @ 8:00 am - June 22, 2017 @ 5:00 pm
Dublin Ireland, Dublin, Ireland

IMPLEMENT AN EFFECTIVE, COMPLIANT PROGRAM THAT ENSURES EFFICACY, SAFETY AND PRODUCT SURVIVAL Join Novatek this year in Dublin, Ireland as we exhibit and speak at this year's Stability Event! Novatek Presentation: User Requirements & Implementation of a Risk Based, Compliant Stability Management System based on the FDA New draft Guidance on DATA Integrity Speaker: Mr. Parsa Famili, President and CEO, Novatek International Key Learnings: Manual systems vs. Computerized systems Benefits of Compliant Computerized Stability System Components of a Compliant Stability System…

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August 2017

IVT’s 3rd Annual Data Integrity Validation Event

August 16, 2017 @ 8:00 am - August 17, 2017 @ 5:00 pm
Westin San Diego, 400 West Broadway
San Diego, 92101 United States

Join us at this year's IVT 3rd Annual Data Integrity Validation Event! With more than a year of adjusting to FDA’s Data Integrity and Compliance with cGMP Guidance underway, take this opportunity to reconvene with your peers to benchmark your processes and implement ALCOA+ principals to ensure a data integrity culture throughout your entire organization. Key Topics Include: ALCOA+ Principles Design Controls Inspection Preparation Continual Gap Analysis Regulatory Update Laboratory Assessments Risk-Based Approaches Robust CAPA Audit Trail Monitoring Contact us…

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September 2017

2017 PDA/FDA Joint Regulatory Conference

September 11, 2017 @ 8:00 am - September 13, 2017 @ 5:00 pm
Renaissance Washington, DC Hotel, 999 9th Street NW
Washington, DC, MD 20001 United States

Novatek will be exhibiting at this year's PDA/FDA Joint Regulatory Conference in September! This year's theme: Ensuring Product Quality in an Era of Innovative Therapies Visit us at Booth 37 to learn more about our regulatory compliant software solutions.  With the Rise of Risk-Based Approach in pharmaceutical and biotech manufacturing this is the ideal conference where industry guidance forges with best practice approaches. Contact us in advance to reserve a meeting and see a live demonstration of any of our quality…

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October 2017

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FREE

CONTAMINATION CONTROL WEBINAR SERIES: Risk-Based EM

October 11, 2017 @ 2:00 pm - 3:00 pm

Join us as we continue our complimentary Contamination Control Webinar Series next month on Wed. Oct 11, 2017 2:00 PM - 3:00 PM EDT With the FDA emphasis on risk based approach for Quality Systems it is no longer good enough to react to problems during pharmaceutical manufacturing, after they occur. Companies are required to implement predictive approaches to identifying problems before they occur. This presentation will use a case study to illustrate how a risk based approach to environmental…

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12th Annual PDA Global Conference on Pharmaceutical Microbiology

October 16, 2017 @ 8:00 am - October 18, 2017 @ 5:00 pm
Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Rd
North Bethesda, MD 20852 United States

It is no doubt that our long standing relationship with PDA reaches new heights every year! And one of our favourite events to participate in every year is the Annual PDA Global Conference on Pharmaceutical Microbiology.  Find us this year at Booth 101 and GET YOUR 101 on Risk-Based Environmental Monitoring.  Learn how an automated and dedicated EM software program can help you identify contamination sooner, decrease product delays to market, and reduce overall regulatory & business risks. This year's…

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IVT’s 23rd Annual Validation Week

October 17, 2017 @ 8:00 am - October 19, 2017 @ 5:00 pm
DoubleTree by Hilton Center City, 237 South Broad Street
Philadelphia, PA 19107 United States

Join Novatek at IVT's 23rd Annual Validation Week this October in Philadelphia! Novatek is a proud sponsor and exhibitor of this Industry Gold Standard of Validation Events! IVT's Annual Validation Week is to provide the most comprehensive information on new global regulations, technology advances and industry case models for developing, implementing and deploying validation procedures enterprise-wide. Program features include: customizable content for professionals from bio/pharma and medical device fields. Over 40 Sessions All Dedicated to Validation and GMP Practice Tailor the…

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November 2017

2017 AAPS Annual Meeting and Exposition

November 12, 2017 @ 8:00 am - November 15, 2017 @ 5:00 pm
San Diego Convention Center, 111 West Harbor Drive
San Diego, 92101 United States

Join Novatek in San Diego this year for the 2017 AAPS Annual Meeting and Exposition!  Find us at Booth 410 and discover how the NOVA-LIMS Product Suite can provide your people the right information at the right time to make the right decisions! The 2017 AAPS Annual Meeting and Exposition programming will focus on five themes: Advanced Formulation Characterization Approaches Patient-Centered Innovations in Healthcare Technology Products for Pediatrics: It’s Not Child’s Play Improving Inter-organization Collaboration Cancer Moonshot: Emerging Modalities for Oncology…

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2017 Congrès International A3P

November 14, 2017 @ 8:00 am - November 16, 2017 @ 5:00 pm
Le Bellevue Centre de Congrès Place, Espace Bellevue, , France
Biarritz , 64200 France

For over three years now, Novatek has been proudly attending A3P's Annual Congress in Biarritz, France.  Join us at KIOSK C8 to learn more about the Nova-LIMS product suite and our outstanding capability that assures your quality manufacturing goals are being met and that your processes are always in a state of control. Contact us in advance to reserve a meeting and see a live demonstration of any of our quality products: sales@ntint.com. For more details & to register yourself follow this…

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December 2017

IVT Stability Testing

December 5, 2017 @ 8:00 am - December 7, 2017 @ 5:00 pm

Have you attended IVT's Lab Week yet? From reviewing core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing, IVT’s annual Stability Testing summit is the flagship event for stability professionals to convene in order to develop and hone your organization’s stability testing procedures. Join us as we showcase Nova-Stability, the industries most reliable software solution that has the ability to perform all types of…

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