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Rouging in Pharmaceutical Water System

Per-Ake Olsson

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)

FDA citations on cleaning, disinfection & sterilisation

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. 

FDA’s Quality Management Maturity & Quality Ratings Program

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.


Application of AI & ML in pharmaceutical Industry

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

Predictive Maintenance in Pharma Manufacturing

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.


Revised Annex 1 Draft : GMP for sterile products

Dr AJ van Zyl   will present  an overview of the New draft Annex 1 of the EU GMP's


GMP Req for Pharmaceutical Gases and Clean Compressed Air

Stephan Neuman  will present  an overview on the applicable regulations, norms and guidelines and also some common practices.


Determination of Metal Impurities in Pharma Product

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


Risk-Based approach in CSV

Sara Levy - In today’s webinar  Sara Levy will explain how to implement a sound Risk Management Programme while validating a Computer system 



Inspection of Injectable Products for Visible Particulates

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.



Good Practices for computerised systems in Gxp environment

Yves Samson :  The presentation will cover various good practices for computerised systems in GXP environment. 



Smart Robotic Solutions for Pharma Applications

Rudolf M. Weiss  will present the opportunities & challenges in Robotic solutions for Pharma Manufacturing. 



Microbiological Quality Considerations in N S D Mfg.

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. 



Maintaining Compliant Critical Utilities

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. 

Design , Qualification and Operation of Ambient WFI Systems

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. 

Efficient Use of 505 b2 Pathway to Enter US Market

Dr. Joga Gobburru :  Dr. Joga Gobburu outlines a methodical approach to achieve a successful drug development pathway.

Overcoming Common Cleaning Challenges

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.

Digitalization for Data Integrity & Regulatory Compliance

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.

ICH Q5A updates and its Impact on BioProcessing

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.

The 5-Step Checklist For A More Mature, Robust Q M S

In this webinar  Tobias Kuners presents a  5-step checklist & systems development approach for  a mature, robust Quality Management System. 

The information collected when you register for a webinar will not be shared with any organization and will not be used for any commercial purposes. We follow the provisions of Indian Information Technology Act  to protect your data. 

pbpwindia@gmail.com

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