Pharma Best Practices Webinars
Pharma Best Practices Webinars
  • Видео 118
  • Просмотров 501 606
Revised Schedule M Critical Requirements for Manufacture of Biological Products
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 Quality System and Risk Management
3. Seed Management (Seed lots/Cell Banks)
4. Personnel, Material, Premises and Equipment
5. Containment and Biosafety Risk Levels
6. Cleanroom classifications
7. Biological products Production and Batch processing Records
8. Biological Process Validations
9. Quality Con...
Просмотров: 287

Видео

Understanding Computer System Validation requirements as per revised Schedule M
Просмотров 954Месяц назад
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
Просмотров 583Месяц назад
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
Просмотров 9032 месяца назад
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
Просмотров 8603 месяца назад
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
Просмотров 1,1 тыс.3 месяца назад
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
Просмотров 1,3 тыс.3 месяца назад
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
Просмотров 2,7 тыс.3 месяца назад
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
Просмотров 1,9 тыс.Год назад
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
Просмотров 3,1 тыс.Год назад
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
Просмотров 854Год назад
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’
Просмотров 6 тыс.Год назад
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
Просмотров 2,4 тыс.Год назад
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
Просмотров 7 тыс.2 года назад
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
Просмотров 1,5 тыс.2 года назад
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
Просмотров 7 тыс.2 года назад
Revised Annex 1 GMP for sterile products
GMP Requirements for Pharmaceutical Gases and Clean Compressed Air
Просмотров 4,8 тыс.2 года назад
GMP Requirements for Pharmaceutical Gases and Clean Compressed Air
Determination of Metal Impurities in Pharmaceutical Products
Просмотров 1,6 тыс.2 года назад
Determination of Metal Impurities in Pharmaceutical Products
Risk Based approach in CSV
Просмотров 6 тыс.2 года назад
Risk Based approach in CSV
Inspection of Injectable Products for Visible Particulates FDA Guidance
Просмотров 4,1 тыс.2 года назад
Inspection of Injectable Products for Visible Particulates FDA Guidance
Good Practices for computerised systems in regulated ‘GxP’ environments
Просмотров 6 тыс.2 года назад
Good Practices for computerised systems in regulated ‘GxP’ environments
Smart Robotic Solutions for Pharma Applications - Opportunities and Challenges
Просмотров 2,3 тыс.2 года назад
Smart Robotic Solutions for Pharma Applications - Opportunities and Challenges
Microbiological Quality Considerations in Non sterile Drug Manufacturing per FDA’s Guidance
Просмотров 2,5 тыс.2 года назад
Microbiological Quality Considerations in Non sterile Drug Manufacturing per FDA’s Guidance
Maintaining Compliant Critical Utilities
Просмотров 2,2 тыс.2 года назад
Maintaining Compliant Critical Utilities
Design , Qualification and Operation of Ambient WFI Systems with a focus on Asian regions
Просмотров 3,1 тыс.2 года назад
Design , Qualification and Operation of Ambient WFI Systems with a focus on Asian regions
Efficient Use of 505 b2 Pathway to Enter US Market
Просмотров 1,9 тыс.2 года назад
Efficient Use of 505 b2 Pathway to Enter US Market
Overcoming Common Cleaning Challenges
Просмотров 2,2 тыс.2 года назад
Overcoming Common Cleaning Challenges
Digitalization for Data Integrity & Regulatory Compliance
Просмотров 2,4 тыс.2 года назад
Digitalization for Data Integrity & Regulatory Compliance
ICH Q5A updates and its Impact on BioProcessing
Просмотров 2,2 тыс.2 года назад
ICH Q5A updates and its Impact on BioProcessing
The 5 Step Checklist For A More Mature, Robust Quality Management System
Просмотров 1,7 тыс.2 года назад
The 5 Step Checklist For A More Mature, Robust Quality Management System