Industry Trainings

2016-2018 PDA Training & Research Institute Courses (PDA TRI) for Aseptic Processing Training Program

Novatek Presentation: Trending EM Data and Considerations for Automation

Novatek Case Study: How Pattern Recognition and Trending Assist in Root Cause Analysis

Key Learnings:

  • This case study is a real world exercise on how a to use a process based automated system to determine the root cause of multiple contamination events in a Grade D room.
  • The case study walks students through a multi- step process using various methods for analyzing excursions to determine corrective actions.
  • Students then learn how to use trending and pattern recognition to compare all of the data simultaneously to determine the root cause of the contamination.

Click here to learn more about PDA TRI: https://www.pda.org/courses/about-pda-education

Speaker: Mike O’Grady

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Institute of Validation Technology (IVT) | Speaker & Presentations

IVT’s 5th Annual Microbiology
June 14-16, 2017
Philadelphia, PA USA

Novatek Presentation: Risk Based Environmental Monitoring (EM) and EM Data Management and Trending Presentation Series

Non-viable air, viable air, and surface monitoring of controlled environments is not a new concept and has been a regulatory requirement for many years. In the past, many companies selected Environmental Monitoring (EM) sample locations based on a grid approach of dividing up the rooms and taking samples inside all of the grids. Current regulatory requirements involve taking risk based approaches in the manufacturing of products, including Environmental Monitoring. Does your current EM Program consist of many floor and wall sample locations? Do you ever ask yourself if the data you are collecting every week/month/year in your EM Program is value added?

Current regulatory expectations are that your EM Program is based on risk of microbial contamination in your process. Formal risk assessments should be performed to justify your EM sample site locations and frequencies. In doing so, your EM Program will ensure that the data you are collecting is meaningful and can help to identify potential contamination problems in your products and processes. This presentation will discuss how to establish a risk-based Environmental Monitoring Program. During this session we will discuss how to set up a new Environmental Monitoring Program based on risk as well as how to perform a reassessment of your current Environmental Monitoring Program to re-establish sampling locations and frequencies based on results of your risk assessments coupled with the knowledge gained from your current EM Program historical data.

Once you have a risk based EM Program in place, you need to manage the data you are collecting. A great way to gain efficiencies is by using an automated system for environmental monitoring. The Novatek Environmental Monitoring data management and trending software system will be presented.

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, risk based sample selections and sampling frequencies
  • Learn how to optimize your EM Program with use of an automated system while gaining efficiencies

Speaker: Cheryl Zaman-Zadeh & Marsha Stabler Hardiman

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Institute of Validation Technology (IVT) | Speaker & Presentations

IVT’s Stability Testing Europe
June 20-22, 2017
Dublin, Ireland

Novatek Presentation: User Requirements & Implementation of a Risk Based, Compliant Stability Management System based on the FDA New draft Guidance on DATA Integrity

Key Learnings:

  • Benefits of Compliant Stability System
  • Stability System Components
  • Stability User Requirements Based on Inherent Risks
  • New FDA draft Guideline “DATA Integrity”
  • Vendors  and Supplier Qualification
  • Implementation and Validation Process and Timeline
  • Preparation for Go-Live

Speaker: Parsa Famili, President & CEO, Novatek International

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IPA ‘s Annual Stability Program Conference | Speaker & Presentations

May 31 – June 2, 2017
Montreal, Canada

Novatek Presentation: User Requirements & Implementation of a Risk Based, Compliant Stability Management System based on the FDA New draft Guidance on DATA Integrity

Key Learnings:

  • Benefits of Compliant Stability System
  • Stability System Components
  • Stability User Requirements Based on Inherent Risks
  • New FDA draft Guideline “DATA Integrity”
  • Vendors  and Supplier Qualification
  • Implementation and Validation Process and Timeline
  • Preparation for Go-Live

Speaker: Parsa Famili, President & CEO, Novatek International

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