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  • Webinar Registration
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  • Recorded Webinars
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EMA & FDA Expectations in Aseptic Processing

In this webinar Vipul Doshi -Chief Quality and Compliance Officer at Zydus Cadila will discuss GMP compliance in Aseptic Processing – What the EMA & FDA Expects.

Regulatory Compliance through S D M A S

Dr. M. Damodharan :  In this webinar, Sai Life Science is presenting the industry first such solution deployed successfully and their benefits in handling instrument integration, data storage and archival functions and heading towards the fully paperless lab. 

Approach to Sustainable Cleaning

Paul Lopolito & Richard Chai : Sustainability is a common goal within the USA, Europe, Asia, and other parts of the world, but the approach to sustainability will depend on the site, corporation, locality, national regulations, culture, people, manufacturing process, and environmental influences. This presentation shares some of these examples.

Changed Regulations for Pharma Water Systems

Nissan Cohen & Susan Cleary - The presentation will cover the new (changed) regulations, what it means for the pharma industry.  The talk will also discuss points about automation, and device connectivity for inline monitoring on water system, and continuous monitoring, as well as managing and trending the data to meet with regulatory requirements.   

Multivariate Data Modeling in C P V

Zuwei Jin : Main Topics covered in the Webinar:

Introduction Of MVDA application in CPV

How MVDA works

How on-line MVDA works

How CPV can be achieved throughout stage 1, 2, and 3                           

3D printing of tablets – A new era of pharma manufacturing

Dr. Thomas Kipping  will present a novel melt drop technology where the 3D printed geometry is created by individual deposition of polymer droplets.

                                                  

ICH Q12 -A New approach to Product Life Cycle Management

Saroj Ramdas : In this webinar you will learn Various tools and approaches defined in ICH Q12 to facilitate CMC change management including  

Established Conditions (ECs) 

Risk-Based Reporting Categories Product Lifecycle Management (PLCM) Document 

Post-approval Change Management Protocol (PACMP)

                                                  

Maximising Product Sterility Assurance

Aaron Mertens : This webinar will present technology to Maximise Sterility Assurance. 

                                                  

CSA What Regulators Expect !

Ian Lucas will give a brief background on why CSA was introduced, and what is probably wrong and right with our current CSV approach. It will also provide practical examples on how to implement CSV within your organization.

                                                  

Net Zero in Pharma:Is it Possible, Practical, & AffordablE?

Keith Beattie: Keith will give some personal thoughts, views and predictions based on his two decades of working on sustainability programmes with many of the leading pharma companies around the world.

                                                  

In-silico Forecast of PERL's in Single Use Technology

Dr. Armin Hauk:  A mathematical Model is presented  for In-silico Forecast of Process Equipment Related Leachable ( PERLs ) in Single Use Technology.                                                       

Getting To and Through Post Approval Stability Studies

John O'Neill -This presentation will explore the stability steps required to arrive at Product regulatory approval as well as the numerous and diverse objectives to be achieved while conducting post-approval stability studies. 

Augmented Reality in Pharma Manufacturing

Frederik Thiele :  This webinar presents use of AR in Pharma Manufacturing and presents Use Case with Lion Suite. 

Use of QRM in Clean Room Contamination control

Jim Polarine & Dan Klein : This seminar will cover a risk-based approach to an Aspergillus brasiliensis and Chaetomium contamination in a Cell and Gene Therapy Cleanroom.

Container Closure Integrity testing - tdlas as a tool

Ronald Koch -In this Webinar a detailed presentation is given about  the technology, use and application of the Tuneable Diode Laser Absorption Spectroscopy (TDLAS) technology for CCIT. 

Analytical Lifecycle Management

Joachim Ermer -In this Webinar Learn  

Development towards life cycle approaches 

Draft: Analytical Target Profile (ATP) and 3-Stage approach

ICH Q12

ICH Q2 Revision and new Q14 Guideline

Lifecycle Approach to Process Validation

Tara Scherder & Keyur Doshi : In this webinar  learn how science and risk-based principles can be applied across the process lifecycle  . 

What makes a Quality Management System Effective?

Karen Ginsbury : The objective of this webinar is to understand what Quality is and what a QMS is supposed to do and how it should do it. Where the GMPs fit into the QMS and how, with intense and close regulatory scrutiny, is it possible to manage a truly effectiveness and robust system.

Validation 4 0 : the Relation to QbD & Pharma 4 0

Michelle Vuolo & Dave Margetts : This webinar will contain extracts from the SIG’s work including: An introduction to Validation 4.0 based on recent PE article: ‘Laying the foundation for Validation 4.0” including an explanation of the conceptual model that is being developed within the SIG. The relevance of QbD and Pharma 4.0, using case studies on continuous verification for OSD 

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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