Pharma Best Practices Webinars
Pharma Best Practices Webinars
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ISPE India Foundation
ISPE India Foundation
We are Proud of this MADE IN INDIA Not for Profit Foundation Nurtured by Indians over past 15 years who worked pro bono for the Foundation.
The passion and the zeal of Local Indian Trustees of this FOUNDATION and their dedication has created a unique platform to share knowledge, impart training through educational sessions and a platform to network
ISPE INDIA is the industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence and regulatory insights to enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients.
zhlédnutí: 131

Video

ISPE India Annual Conference 2024
zhlédnutí 318Před dnem
ISPE India invites you on a transformative journey at Pharma 4.0 conference “Advances in Automation, Robotics and Digital transformation where subject matter experts and industry leaders will showcase the latest in digital technologies and data driven strategies reshaping Pharmaceutical Manufacturing and supply chain
Revised Schedule M Critical Requirements for Manufacture of Biological Products
zhlédnutí 347Před 2 měsíci
The Webinar will provide the details about New and Critical Requirements for Manufacture of Biological Products, for the manufacture, control, and testing of biological products. The webinar will discuss the following topics broadly. 1. The manufacture, control, and testing of biological products for human use from starting materials and preparations to the finished product. 2. Pharmaceutical Q...
Understanding Computer System Validation requirements as per revised Schedule M
zhlédnutí 1,2KPřed 2 měsíci
About the Webinar With the recent notification of Revised Schedule M by CDSCO, ensuring product quality and compliance has become more critical than ever. Computer Systems are playing a critical role in the pharmaceutical operations. To help you navigate these changes on the Computer Systems Compliance in Schedule M, Pharma Best Practices Foundation is proud to present this webinar covering key...
Revised Schedule M Practical approach to implement Quality Risk Management
zhlédnutí 638Před 2 měsíci
About the Webinar Revised Schedule M: Practical approach to implement Quality Risk Management. In this webinar we will discuss following : Basics of Quality Risk Management Process Introduction to principles of Quality Risk Management General overview of QRM Process Introduction to Risk Management Methodology Practical challenges in managing QRM process. Knowledge and Change Management QRM - Go...
Qualification of Analytical Instruments Schedule M, WHO,USP and EU Requirements
zhlédnutí 965Před 3 měsíci
Recent changes to Schedule M of Indian Good Manufacturing Practice refer to guidelines of World Health Organisation . The applicable guidleine is WHO TRS 1019 Annex 3 published in 2019 provides guidelines on validation. Within this Annex, Appendices 5 and 6 cover validation of computerised systems and qualification of equipment respectively. Can these Appendices be applied to the practical and ...
P W Systems compliance to India , US , EU Pharmacopeia using QRM & PAT
zhlédnutí 902Před 4 měsíci
About the Webinar With the recent notification of Revised Schedule M by CDSCO, ensuring product quality and compliance has become more critical than ever. To help you navigate these changes, ISPE India Foundation is proud to present a webinar on “ P. W. Systems compliance to India , US , EU Pharmacopeia using QRM & PAT In this webinar, we will delve into • Understanding the fundamental principl...
Master Revised Schedule M - New Critical Requirements for Manufacture of Oral Solid Dosage Forms
zhlédnutí 1,3KPřed 4 měsíci
About the Webinar: Pharma Best Practices Foundation is pleased to invite you to a webinar where we delve into the intricacies of the Revised Schedule M, focusing specifically on its impact and specific requirements for the manufacture of oral solid dosage forms such as tablets and capsules. This webinar focusing on tablets and capsules explores the specific requirements outlined in the Revised ...
Qualification and Validation principles to meet revised schedule M requirements
zhlédnutí 1,4KPřed 4 měsíci
About the Webinar The Webinar will provide the objective and scope to detail the basic principles of qualification and validation, that can be applied to equipment, utilities, facilities and software within the life sciences industry. The qualification and validation principles are based on a lifecycle approach with the application of risk management principles. The webinar will discuss the fol...
Understanding Revised Schedule M Part II Ensuring Compliance in Sterile Product Manufacturing
zhlédnutí 2,9KPřed 4 měsíci
About the Webinar: With the recent notification of Revised Schedule M by CDSCO, ensuring product quality and compliance has become more critical than ever. To help you navigate these changes, ISPE India Foundation is proud to present this webinar covering key aspects of Part II including : Understanding the fundamental principles underpinning Schedule M Part II,Implementing Good Manufacturing P...
' GMP's for Modern Pharmaceutical Water
zhlédnutí 2KPřed rokem
About the Webinar Historical myths and legend propagations are rampant in pharmaceutical companies. These ingrained myths and legends are due to institutional adoption of procedures which often were written decades ago and are still prevalent in today’s current documentation, SOPs, and actual practice. Unfortunately, little is done to demystify these myths, legends, misconceptions, and misconst...
Rouging in Pharmaceutical Water System
zhlédnutí 3,1KPřed rokem
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) About the Presenter ...
OECD GLPs for in vitro studies
zhlédnutí 865Před rokem
About the Webinar The Introduction to OECD (Organization for Economic Cooperation and Development) GLP Principles session is primarily intended to provide an overview of the guidelines for non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. Add...
Lesson learnt on FDA citations on cleaning, disinfection and sterilization’
zhlédnutí 6KPřed 2 lety
About the Webinar 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 di...
FDA’s Quality Management Maturity and Quality Ratings Program
zhlédnutí 2,4KPřed 2 lety
Planning for FDA’s Increased Focus on Quality Management Maturity and Quality Ratings About the Webinar by Chris Fanelli, Partner, Sidley Austin LLP Daniel Roberts, Senior Director, Regulatory Compliance, Sidley Austin LLP Quality management maturity (QMM) is one of the new buzzwords in FDA’s Office of Pharmaceutical Quality. According to FDA, QMM means is “the state attained when drug manufact...
Application of Artificial Intelligence AI & Machine Learning ML in pharmaceutical Industry
zhlédnutí 7KPřed 2 lety
Application of Artificial Intelligence AI & Machine Learning ML in pharmaceutical Industry
Predictive Maintenance in Pharma Manufacturing
zhlédnutí 1,6KPřed 2 lety
Predictive Maintenance in Pharma Manufacturing
Revised Annex 1 GMP for sterile products
zhlédnutí 8KPřed 2 lety
Revised Annex 1 GMP for sterile products
GMP Requirements for Pharmaceutical Gases and Clean Compressed Air
zhlédnutí 4,9KPřed 2 lety
GMP Requirements for Pharmaceutical Gases and Clean Compressed Air
Determination of Metal Impurities in Pharmaceutical Products
zhlédnutí 1,6KPřed 2 lety
Determination of Metal Impurities in Pharmaceutical Products
Risk Based approach in CSV
zhlédnutí 6KPřed 2 lety
Risk Based approach in CSV
Inspection of Injectable Products for Visible Particulates FDA Guidance
zhlédnutí 4,2KPřed 2 lety
Inspection of Injectable Products for Visible Particulates FDA Guidance
Good Practices for computerised systems in regulated ‘GxP’ environments
zhlédnutí 6KPřed 2 lety
Good Practices for computerised systems in regulated ‘GxP’ environments
Smart Robotic Solutions for Pharma Applications - Opportunities and Challenges
zhlédnutí 2,4KPřed 2 lety
Smart Robotic Solutions for Pharma Applications - Opportunities and Challenges
Microbiological Quality Considerations in Non sterile Drug Manufacturing per FDA’s Guidance
zhlédnutí 2,5KPřed 2 lety
Microbiological Quality Considerations in Non sterile Drug Manufacturing per FDA’s Guidance
Maintaining Compliant Critical Utilities
zhlédnutí 2,2KPřed 2 lety
Maintaining Compliant Critical Utilities
Design , Qualification and Operation of Ambient WFI Systems with a focus on Asian regions
zhlédnutí 3,2KPřed 2 lety
Design , Qualification and Operation of Ambient WFI Systems with a focus on Asian regions
Efficient Use of 505 b2 Pathway to Enter US Market
zhlédnutí 1,9KPřed 2 lety
Efficient Use of 505 b2 Pathway to Enter US Market
Overcoming Common Cleaning Challenges
zhlédnutí 2,2KPřed 2 lety
Overcoming Common Cleaning Challenges
Digitalization for Data Integrity & Regulatory Compliance
zhlédnutí 2,4KPřed 2 lety
Digitalization for Data Integrity & Regulatory Compliance