NOVATEK INTERNATIONAL WORKSHOP #PLA2019


Cleaning Validation in a pharmaceutical manufacturing environment

Overview

Cleaning-Validation Management is addressing one of the major priorities in the pharmaceutical industry. Combining digital technology to support cGxP compliant industries in handling enormous amounts of complex data, the endless combinations of variables and required calculations in cleaning processes with a comprehensive and easy to use application.

Avoiding contamination is a major priority in the pharmaceutical industry. The EU Guidelines to GMP Annex 15 Qualification and Validation requires cleaning validation to be based on a scientific and risk-based approach. “Visually clean only” is no longer acceptable.

Prevention of cross-contamination is one of the main topics in the recent updates of the EU GMP Guide. The control of cross-contamination has a very important role in maintaining product quality.

Session learnings

  • Understand the Worst-Case Determination Methods and the role of automation for Worst Case analysis  
  • Recognize the components of common MAC equations and the role of automation for MAC calculations  
  • Learn how automation can streamline evaluating the eligibility of new products and equipment in a facility.
  • Realize the difference between paper-based and automated Cleaning Validation Management systems and processes.
  • Insights necessary to build a framework for a scientific, risk-based approach to cleaning of products. We will address how well established and accepted risk assessment methods can be used to develop health-based limits such as ADE and Maximum Safe Carryover (MSC) values.
  • Learnings will be applicable to the development and validation of cleaning processes for all health, medical, cosmetics, and consumer products, which includes pharmaceuticals (APIs, dosage forms, veterinary, biologics, and clinical supplies), dietary supplements, and medical devices.

Areas covered in this session 

  • Cleaning Validation requirements.
  • Cleaning Validation Guidelines and Industry documents.
  • Automation architecture for Cleaning Validation.
  • What automation solution options are available to manage Cleaning Validation.

 

Who should benefit

Quality control, R&D, QA, Regulatory compliance personnel, Cleaning Validation specialist, Validation Managers.

Why should you attend 

All over the world, Cleaning Validation issues occur on a daily basis, further, the complexity in maintaining the validated state in a dynamic production environment where equipment, products, APIs, formulations, batch size are constantly changing.

In this session, we give a practical automation approach to deal with this issue rather than the theoretical solution. Also, we will be showcasing a unique data integrity solution for regulated industries Selecting a solution is tricky enough without adding the complexity of technological choices.

This workshop will provide insight into the benefits associated with the automation of a Risk-Based Cleaning Validation process

contamination control novate paperless lab academy

Presenter

marc voderman paperless lab academy

Name: Marc Voderman

Title: Director Europe

 

Information Technology Professional since 1983. More than 25 years of experience in the process manufacturing industry (Pharma, food, and chemicals). Various senior leadership positions at international operating Enterprise Software vendors. Worked with Global manufacturing and healthcare companies in North America and the EMEA region (Europe Middle East & Africa).
Specialized in the deployment of business applications and Information (data). Information for the day to day operations and as a strategic problem-solving and decision-making instrument.
Business solutions; ERP solutions, Human resources, Customer relationship management, Supply Chain
Management, Regulatory compliance solutions, Data Science.
Languages Dutch (native), Fluent in German and English.

Aram Montazami paperless lab academy

Name: Aram Montazami

Title: Vice President of R&D, Co-Founder and Member of the Board at Novatek International Network of Corporation

 

With twenty years of experience developing products for regulated and healthcare industries, Mr. Aram Montazami, has successfully co-founded Novatek International, Novatek Medical Data Systems, Cognistat, and Cognistat Sport.  Mr. Montazami plays an active role in the management of the Novatek Engineering Team as well as the management of the R&D activities with a %100 success rate over the last 15 years. With a background in Electrical and Computer Engineering and added expertise in regulated (GAMP, GxP, etc) and niche market product development, Mr. Montazami has successfully managed the development and the implementation of over 18 software products ranging from thick client-server to Saas solutions to clients worldwide.

Novatek International’s mission is to produce regulatory compliant software solutions to the pharmaceutical, biotech and other health-care industries. Our goal is to improve patient safety by producing solutions that reduce the risks associated with pharmaceutical manufacturing and contribute to product quality.

Since 1996, Novatek International has been a global leader in providing innovative and comprehensive, process-driven software solutions. With 20 years of successful global installations, Novatek has developed an extensive base of regulatory knowledge giving you the peace of mind knowing you are in compliance with regulatory guidelines. Your Data is more than just a number. It has the power to drive compliance and improve your business.

Novatek main website:  https://ntint.com/about-us/

About Reduce-Risk.com http://reduce-risk.com/

The FDA identifies the primary reason for drug shortages to be product quality issues. Companies are now expected to adopt risk-based programs to identify problems before they occur. Novatek understands the struggle that these companies face and that is why we have responded by creating reduce-risk.com, a platform to educate our industry on how to leverage technology to achieve compliance.