About the Webinar This webinar will explain rouging in pharmaceutical water system and cover the following:
Explanation of rouge and rouge development
What different guidance’s say about rouge control What different rouge tests have find out in regards to rouge development
How to design and operate a water system to avoid rouging
How to remove rouge
Q&A session (15 minutes)
Richard Chai & Jim Polarine: Microbial and product contamination is one of the major challenges faced by manufacturing companies within the GMP regulated industries. These contamination events will lead to production downtime, time spent on investigations, product recalls and risk to patient safety. This presentation will look at the past FDA citations (Warning Letters and 483s) related to cleaning and disinfection, process equipment cleaning and sterilisation processes.
Chris Fanelli & Daniel Roberts : This webinar will feature two former FDA enforcement officials: Chris Fanelli and Dan Roberts of Sidley Austin LLP. Chris and Dan will lead an interactive discussion of FDA’s QMM program, and how manufacturers should be preparing for the implementation of a quality ratings system.
Vijay Yadav: The agenda for the webinar is given below:
Introduction on AI/ML
Digital, Data & Analytics challenges in pharma industry
best practices AI/ML
Uses Cases in pharma
One Specific Use Case: Visual Inspection Using AI/ML
Milind Yedkar: In this webinar we will discuss two approaches to Predictive Maintenance and the pros and limitations of each. We will also learn how PdM can be an integral part of Digitalizing an organization’s operations.
Dr AJ van Zyl will present an overview of the New draft Annex 1 of the EU GMP's
Stephan Neuman will present an overview on the applicable regulations, norms and guidelines and also some common practices.
Ingrid Hayenga, PhD
Within this seminar you will hear about: The current regulatory requirements regarding metal impurities determination in various Pharmacopoeia (USP, EP, IP) The various possibilities to approach the metal impurity determination The reference material which Merck offers to help your analysis produce accurate results
Sara Levy - In today’s webinar Sara Levy will explain how to implement a sound Risk Management Programme while validating a Computer system
DANIEL ROBERTS & CHRISTOPHER FANELLI : The presentation will offer insight into FDA’s recommendation that manufacturers develop and implement a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination.
Yves Samson : The presentation will cover various good practices for computerised systems in GXP environment.
Rudolf M. Weiss will present the opportunities & challenges in Robotic solutions for Pharma Manufacturing.
Ziva Abraham : The focus of the webinar be on key elements of the draft guidance, Assessing risk on non-sterile product, what you need to know about USP specified organisms vs the focus on objectionable microorganisms in the draft guidance
and Significance of microbial identification in pathogen specific assessments.
Mitchell wheeler & Sarah Harter : During the webinar, best practices to ensure critical utilities are qualified and maintained per FDA requirements, industry guidance and applicable regulations will be presented.
Sanjay Kolawale and Fritz Röder: This webinar is intended to give guidance on how to design, operate and qualify ambient WFI systems with a focus on Asian regions.
Dr. Joga Gobburru : Dr. Joga Gobburu outlines a methodical approach to achieve a successful drug development pathway.
Paul Lopolito & Richard Chai: This presentation will enable the participants to understand the current regulations related to cleaning, and various factors that can affect the effectiveness of the cleaning process such as cleaning procedures. Examples of the cleaning challenges and its remediation procedure will be discussed in detail, together with case studies.
Bob McDowall: This webinar will present an overall laboratory automation strategy and how it should be implemented with Practical examples and advice from case studies.
Manjula Aysola : The upcoming revision of ICHQ5A will include the use of new technologies and viral clearance strategies to also examine cell, gene therapies and newer vaccine paradigms such as virus like particles, subunit proteins, and viral vectors. This webinar will focus on presenting the impact to industry from these updates.
In this webinar Tobias Kuners presents a 5-step checklist & systems development approach for a mature, robust Quality Management System.
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