In this webinar Vikas Dandekar Editor (Pharma & Healthcare) - ET Prime will moderate a panel discussion with Dr Rajiv Desai Executive Vice President - Global Quality Head at Lupin Limited, Rajendra Dadhich Senior Vice President - Corporate Quality at IPCA and Robert A. Rhoades Managing Partner at Validant about their perspective on Best Practices to be always ready for an FDA Inspection.
Ensuring Measurement Accuracy in the Validation of Sterile Thermal Processes by- Dennis Plante
This presentation will cover following :
Validation History / Trends
Regulatory Requirements / CTQ’s
Measurement Accuracy / Uncertainty
Calibration Requirements / Sources of Error
Sensors /Sources of Error
This talk expands on the previous Factorytalk webinar run for ISPE India and will use several case-studies to further detail how running Process Risk Assessments early in projects can drive a leaner validation approach. We will show how to break down processes into the resulting risks and required controls including their relevance to Data Integrity. We will look at corresponding examples of how unscripted testing can reduce verification phase efforts and time.
In this webinar we will discuss different areas around functionality and technology for a comprehensive overview:
Apply OEE monitoring to the entire production process.
Reduce complexity of delivery by a new cloud / edge architecture.
Apply a broader set of data analytics on the gathered shop floor data for further insights.
Use AI to be able to predict key batch events or downtime causes before they happen.
Session 1 : Preventive Maintenance on Stainless Steel System by Richard Chai & Paul Lopolito
Session 2 : A Risk Based Contamination Control Strategy by Jim Polarine
Session 3 : Surface decontamination with VHP – Fundamentals & Facility Integrations by Nicholas Tan & Bruno Aze
"A Rational Approach to Formulation Design" by R. Christian Moreton, B.Pharm., M.Sc., Ph.D. Partner, FinnBrit Consulting,
"Excipient and Supplier Qualification for High Quality Formulations" by David R. Schoneker President/Owner of Black Diamond Regulatory Consulting, LLC.
Lynne A. Ensor, Ph. D., Vice President – Technical, Parexel International
This webinar will describe the foundation for KASA and how it will be utilized for knowledge management of biopharmaceuticals and their associated facilities.
This webinar will cover following :
Need for OOS investigation and Regulatory outlook
Investigation methodology and investigation tools,
Data to be reviewed for different kinds of OOS results,
Assignable and non-assignable causes
Corrective and Preventive actions
How to write good investigation report.
Dr. Mrunal Jaywant
The webinar provides brief outline of analytical method transfer activity and signifies its role in product life cycle management.
Joe Hoff & Keith Dodson:
This educational session will address the changing needs for the manufacturing of biologics and the rationale for the use of robotics and automation in aseptic fill and finish processing of these products.
Mark F. Witcher, Ph.D.
The one-hour seminar covers the recent evolution of FDA’s 2011 Process Validation (PV) guidance into a more effective Lifecycle Process Development and Validation (LPDV) paradigm. The original PV approach, as supported by the guidance ICH Q8 (R2) – Pharmaceutical Development and ICH Q9 – Quality Risk Management, has serious fundamental weaknesses.
In this webinar, we will explore the basis and development of a good CAPA program including what critical quality oversight and management review should entail. We will also explore the 7 tenants of a good CAPA process.
Dr. Tim Sandle
The following topics are covered:
Cleaning validation & GMPs
Microbiological tests and acceptance criteria
Why failures happen
Nina S. Cauchon, PhD & Jill Beierle, MS
This webinar discusses innovative solutions for assembling, distributing, and reviewing regulatory information such as structured content data management (SCDM) solutions. SCDM may aid in the efficient processing of data and create opportunities for automation and machine learning in its interpretation and can potentially modernize the compilation of quality data in regulatory submissions.
Sarel Chen Tov
This webinar will discuss the critical success factors for a successful Technology Transfer for Bio Pharmaceuticals.
This webinar will cover
Risk based inspections-API Whitelisting
JAP/JRP process used for MRAs, whitelisting and PIC/S- Future look at regulatory strategy
Desktop GMP assessment- Recent inspection findings
This presentation deals with Clean Room Contamination Control by Computational Fluid Dynamic Simulation.
This webinar will discuss how to get the most benefit from a QRM program so that it delivers its full potential as a powerful tool for decision making, prioritisation, efficiency, continuous improvement, training and knowledge management.”
This webinar introduces the concept of robotic process automation (RPA) and discusses how the technology may be used within a GAMP® framework to support both non-GxP and GxP processes.
This Educational Session will cover a risk-based approach to a cleaning and disinfection program and new recent case studies in contamination control. Details will be provided on how to follow a risk-based approach for cleaning and disinfection using good science.