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October 2020

SPEAKER VIRTUAL CONFERENCE: IPA Stability Program Conference 2020 PART 2

October 28, 2020 @ 7:30 am - 5:00 pm

IPA is delighted to be hosting its Stability Program Conference on October 21 & 28, 2020 online. This interactive and comprehensive virtual conference will provide attendees in learning how to establish the most effective, compliant, and improving your stability program from early stage development to commercial products. This includes latest regulatory compliance updates, scientific discoveries, technologies and innovations in the pharmaceutical, biopharmaceutical and allied industries. Going virtual this year! Attend the conference from anywhere from the comfort of your computer.…

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November 2020

VIRTUAL CONFERENCE: Global HealthTech Summit 2020

November 11, 2020 - November 13, 2020

Celebrate the reveal of the World's Most Innovative HealthTech Startups in 2020 and Corporate partnerships at the Global HealthTech Summit Nov. 11-13, 2020. Novatek will be both exhibiting and participating on Day 3: Ecosystem Discovery Through the Eyes of the Digital Health Startups Panel - CANADA TRACK There is no better way to understand an ecosystem than asking entrepreneurs that are navigating all unchartered water to build their digital health solution. On this panel, we hear from 4 HealthTech startups…

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VIRTUAL SYMPOSIUM: PDA Southern California “Risk-Based Approaches during the Pandemic”

November 16, 2020 - November 20, 2020

Join us for 2020 PDA 4th Annual Fall Symposium! Due to the Covid-19 pandemic, we have spread out this virtual symposium over the course of a week instead of our usual one-day symposium to accommodate attendee schedules. We will be discussing “Risk-Based Approaches during the Pandemic”, including Virtual Audits, Contamination Control and Quality Systems. Novatek will be sponsoring and speaking at this year's Symposium: Nov. 16-20, 2020 PST Full event details can be found here: https://www.pda.org/global-event-calendar/event-detail/pda-southern-california-chapter---2020-virtual-4th-annual-fall-symposium

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WEBINAR: Roadmap to Compliance in Environmental Monitoring w/ Merck KGaA

November 18, 2020 @ 8:00 am - 9:00 am

ABOUT THIS WEBINAR:   This webinar will provide an overview of a holistic approach to achieve compliance with good manufacturing practice (GMP) requirements for environmental monitoring (EM) in aseptic manufacturing areas, such as ISO 5 cleanrooms in traditional setup, RABS or isolators. The new EU GMP Annex 1 (Draft 2020) requires EM programs and procedures based on risk analysis. This includes establishment of: sampling plans qualification and validation of methods for EM data analysis traceable and complete documentation. All single…

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December 2020

VIRTUAL TRAINING: PDA 612.1 Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines

December 1, 2020 @ 1:30 pm - 4:30 pm

Novatek is pleased to be part of PDA TRI this year! Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines This training course offers a deep dive into the analysis required for Environmental Monitoring (EM) with specific consideration to cGMP and Data Integrity guidelines. As such, the training course is two-fold. The first portion focuses on primarily data analysis for EM. This is for both routine data analysis as well as the analysis required for excursions…

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VIRTUAL CONFERENCE: Computer & Software Validation & Data Integrity Compliance Congress

December 7, 2020 - December 9, 2020

Did you know that Novatek has a tool to help execute your computer systems and software data up to 50% faster? We'll be showcasing our solution Nova-Screen Capture at this year's KENX event: To this day, CSV and Data Integrity challenges remain high in our rapidly changing environment. In fact, FDA and other regulators continue to find serious findings including; having interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate…

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February 2021

VIRTUAL SUMMIT: PharmaEd Resources Cleaning Validation Summit

February 10, 2021 @ 8:00 am - February 11, 2021 @ 5:00 pm

Can you implement the best science-based, risk-based, and statistics-based approaches for cleaning validation? Today's regulators are now expecting ADE monographs and risk assessments of your organization's cleaning validation programs. Implementing a Risk-Based, Data Integrity Compliant Cleaning Validation Management System SPEAKER: Sheba Zaman, Head of Product Specialists at Novatek International In pharmaceutical manufacturing, risk of contamination is from a broad range of factors such as cross contamination (other pharmaceutical active ingredients), cleaning agents and micro-organisms. Additionally, the risk of contamination may…

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March 2021

PODIUM SPEAKER: 2021 PDA Annual Meeting

March 15, 2021 @ 8:00 am - March 17, 2021 @ 5:00 pm

The 2021 PDA Annual Meeting promises to have something for everyone! This premier conference will offer a new ways to connect!  What will remain constant is that this Conference will highlight what’s in store for the future of pharmaceutical manufacturing. Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes. Watch Novatek's Podium Presentation: Session: B4: CPV/Validation/Lifecycle | 16 March | 14:45…

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WEBINAR: ISPE India Pharma Best Practices Webinar Series – How to Trend & Analyze EM Data

March 20, 2021 @ 12:30 am - March 21, 2021 @ 2:00 am

We are proud to be collaborating again with the very active ISPE India Chapter this December!  With over 40+ webinars under their belt in response to the Global Pandemic, we are so glad we can work with the Chapter to continue the training and development of our industry peers. ISPE India Pharma Best Practices Webinar Series - How to Trend & Analyze EM Data Part 1: EM Trending Requirements Overview on Requirements and Guidelines on EM Data Analysis Considerations for…

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April 2021

WEBINAR SPONSOR: PDA West Coast – EU GMP Annex 1 – Current guidance and the new draft

April 15, 2021 @ 9:00 am - 10:30 am

Novatek is pleased to be an annual sponsor for the PDA West Coast Chapter for 2021! This webinar looks at the latest published draft of EU GMP Annex 1 and considers the key changes, in terms of risk philosophy, contamination control, technology and regulatory thinking. The webinar addresses: Contamination control strategy Quality systems and how they need to connect with sterility assurance Cleanrooms and revised design criteria Disinfection recommendations Personnel controls Aseptic processing technology Speaker: Dr. Tim Sandle, Ph.D. Register:…

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