Pharma Best Practices Webinars
Pharma Best Practices Webinars
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Understanding Computer System Validation requirements as per revised Schedule M
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 aspects of the CSV requirements and best practices for documentation.
About Speaker
Sharmila Valleru is a Director in PwC India, leading the CSV Practice. She is a Subject Matter Expert and a Senior Quality and Regulatory Compliance with more than two decades of experience. She has been assisting Pharma & Lifesciences and Medical Devices companies in the areas of CSV, GxP and IT Compliance. She had assisted both domestic and international companies in the Audits / Gap assessments, Remediations, Training, Automation & Digitalisation.
มุมมอง: 464

วีดีโอ

Revised Schedule M Practical approach to implement Quality Risk Management
มุมมอง 430วันที่ผ่านมา
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
มุมมอง 678หลายเดือนก่อน
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
มุมมอง 783หลายเดือนก่อน
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
มุมมอง 8592 หลายเดือนก่อน
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
มุมมอง 1.1K2 หลายเดือนก่อน
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
มุมมอง 2.3K2 หลายเดือนก่อน
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
มุมมอง 1.8Kปีที่แล้ว
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
มุมมอง 3Kปีที่แล้ว
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
มุมมอง 830ปีที่แล้ว
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’
มุมมอง 6Kปีที่แล้ว
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
มุมมอง 2.4Kปีที่แล้ว
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
มุมมอง 7Kปีที่แล้ว
About the Webinar Pharmaceutical Companies are looking for ways to leverage artificial intelligence and machine learning within thePharmaceutical and the biotech industry. Reports show an increasing number of entities are realizing current use cases, driving the digital future of the tech in the industry. AI and machine learning play a critical role in drug discovery, drug manufacturing, diagno...
Predictive Maintenance in Pharma Manufacturing
มุมมอง 1.5Kปีที่แล้ว
About the Webinar Predictive Maintenance (PdM) is a topic that has been discussed for long. However it is not seen widely in actual implementation. The high cost of sensors acted as one constraint. A bigger challenge was the need to invest in a Centre of Expertise (CoE) staffed with engineers having long years’ experience in this field, before an organization could begin expecting results. Toda...
Revised Annex 1 GMP for sterile products
มุมมอง 7Kปีที่แล้ว
About the Webinar The manufacturing of sterile pharmaceutical products has always offered some challenges to regulators and industry alike. Ensuring appropriate quality and assuring sterility are two important aspects to be considered in the production and control of sterile products. The administration of a contaminated product to patients could have dire consequences. Traditionally, regulator...
GMP Requirements for Pharmaceutical Gases and Clean Compressed Air
มุมมอง 4.6K2 ปีที่แล้ว
GMP Requirements for Pharmaceutical Gases and Clean Compressed Air
Determination of Metal Impurities in Pharmaceutical Products
มุมมอง 1.5K2 ปีที่แล้ว
Determination of Metal Impurities in Pharmaceutical Products
Risk Based approach in CSV
มุมมอง 6K2 ปีที่แล้ว
Risk Based approach in CSV
Inspection of Injectable Products for Visible Particulates FDA Guidance
มุมมอง 4K2 ปีที่แล้ว
Inspection of Injectable Products for Visible Particulates FDA Guidance
Good Practices for computerised systems in regulated ‘GxP’ environments
มุมมอง 6K2 ปีที่แล้ว
Good Practices for computerised systems in regulated ‘GxP’ environments
Smart Robotic Solutions for Pharma Applications - Opportunities and Challenges
มุมมอง 2.3K2 ปีที่แล้ว
Smart Robotic Solutions for Pharma Applications - Opportunities and Challenges
Microbiological Quality Considerations in Non sterile Drug Manufacturing per FDA’s Guidance
มุมมอง 2.4K2 ปีที่แล้ว
Microbiological Quality Considerations in Non sterile Drug Manufacturing per FDA’s Guidance
Maintaining Compliant Critical Utilities
มุมมอง 2.2K2 ปีที่แล้ว
Maintaining Compliant Critical Utilities
Design , Qualification and Operation of Ambient WFI Systems with a focus on Asian regions
มุมมอง 3.1K2 ปีที่แล้ว
Design , Qualification and Operation of Ambient WFI Systems with a focus on Asian regions
Efficient Use of 505 b2 Pathway to Enter US Market
มุมมอง 1.9K2 ปีที่แล้ว
Efficient Use of 505 b2 Pathway to Enter US Market
Overcoming Common Cleaning Challenges
มุมมอง 2.1K2 ปีที่แล้ว
Overcoming Common Cleaning Challenges
Digitalization for Data Integrity & Regulatory Compliance
มุมมอง 2.4K2 ปีที่แล้ว
Digitalization for Data Integrity & Regulatory Compliance
ICH Q5A updates and its Impact on BioProcessing
มุมมอง 2.1K2 ปีที่แล้ว
ICH Q5A updates and its Impact on BioProcessing
The 5 Step Checklist For A More Mature, Robust Quality Management System
มุมมอง 1.6K2 ปีที่แล้ว
The 5 Step Checklist For A More Mature, Robust Quality Management System
EMA & FDA Expectations in Aseptic Processing
มุมมอง 9K2 ปีที่แล้ว
EMA & FDA Expectations in Aseptic Processing