01:34

ISPE India Foundation

03:11

ISPE India Annual Conference 2024

01:36:06

Revised Schedule M Critical Requirements for Manufacture of Biological Products

02:12:48

Understanding Computer System Validation requirements as per revised Schedule M

02:19:43

Revised Schedule M Practical approach to implement Quality Risk Management

01:46:10

Qualification of Analytical Instruments Schedule M, WHO,USP and EU Requirements

01:21:13

P W Systems compliance to India , US , EU Pharmacopeia using QRM & PAT

01:08:00

Master Revised Schedule M – New Critical Requirements for Manufacture of Oral Solid Dosage Forms

02:21:51

Qualification and Validation principles to meet revised schedule M requirements

01:21:43

Understanding Revised Schedule M Part II Ensuring Compliance in Sterile Product Manufacturing

01:28:21

' GMP's for Modern Pharmaceutical Water

01:28:55

Rouging in Pharmaceutical Water System

01:16:52

OECD GLPs for in vitro studies

01:19:22

Lesson learnt on FDA citations on cleaning, disinfection and sterilization’

01:20:57

FDA’s Quality Management Maturity and Quality Ratings Program

01:03:31

Application of Artificial Intelligence AI & Machine Learning ML in pharmaceutical Industry

01:21:24

Predictive Maintenance in Pharma Manufacturing

01:40:59

Revised Annex 1 GMP for sterile products

01:29:26

GMP Requirements for Pharmaceutical Gases and Clean Compressed Air

01:01:10

Determination of Metal Impurities in Pharmaceutical Products

01:36:57

Risk Based approach in CSV

01:39:35

Inspection of Injectable Products for Visible Particulates FDA Guidance

01:46:45

Good Practices for computerised systems in regulated ‘GxP’ environments

53:51

Smart Robotic Solutions for Pharma Applications – Opportunities and Challenges

01:27:28

Microbiological Quality Considerations in Non sterile Drug Manufacturing per FDA’s Guidance

02:18:53

Maintaining Compliant Critical Utilities

01:34:35

Design , Qualification and Operation of Ambient WFI Systems with a focus on Asian regions

59:15

Efficient Use of 505 b2 Pathway to Enter US Market

01:13:16

Overcoming Common Cleaning Challenges

01:35:15

Digitalization for Data Integrity & Regulatory Compliance

01:20:52

ICH Q5A updates and its Impact on BioProcessing

01:15:13

The 5 Step Checklist For A More Mature, Robust Quality Management System

01:57:02

EMA & FDA Expectations in Aseptic Processing

01:59:36

Regulatory Compliance through Scientific Data Management Systems

01:29:12

Approach to Sustainable Cleaning

01:30:57

Changed Regulations for Pharma Water Systems What it means for the Pharma Industry

01:23:19

Multivariate Data Modeling in Continued Process Verification

59:43

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

01:11:55

ICH Q 12 A New Innovative approach to Product Life Cycle Management

01:12:49

Maximising Product Sterility Assurance

01:32:42

CSA/ CSV What Regulators Expect !

01:16:28

Net Zero in Pharma Is it Possible, Practical, and Affordable

01:29:48

In silico Forecast of Process Equipment Related Leachable PERLs in Single Use Technology

01:11:47

Post Approval Stability Studies

01:32:23

Augmented Reality in Pharma Manufacturing

01:28:49

Use of QRM in a Cell & Gene Therapy Clean Room Contamination Control

01:31:02

Laser based Headspace Analysis as a Container Closure Integrity Testing Tool

01:30:33

Analytical Lifecycle Management

02:04:33

Lifecycle Approach to Process Validation

01:26:43

What makes a Quality Management System Effective

01:27:54

Validation 4 0 Objectives, Working Model, & the Relation to QbD & Pharma 4 0

02:07:26

QbD Product Development and Life cycle Management

01:40:23

Challenges in Disinfectant Coupon Testing

01:23:49

Points to consider & Line Design for Pre Use Post Sterilization Integrity test

01:23:20

Thermal Validation of Sterile Process with Wired and Wireless Technology

01:25:45

Data & Digital adaptation in Pharmaceutical Quality Operations

01:29:20

CLEANING VALIDATION Detergent Chemistry, Analysis and Analytical Methods, What Regulators Expect

01:25:21

Regulatory Requirements & Expectations for Cleaning & Disinfection of Controlled Manufacturing Areas

57:33

Rouge Monitoring The Usage of Science based Online Instrumentation to Determine Derouging and Pas

01:25:04

How to Trend & Analyze EM Data