Igor Gorsky & Susan B. Cleary
This webinar describes the use of QRM (quality risk management) in Cleaning Validation and the growing trend of applying this approach to the lifecycle of the product manufacturing process. Establishing of health-based Cleaning Validation limits and using them in MAC equations is also included. Additionally recommendations on the compliant and sustainable programs and regulator expectations for these programs is discussed.
This educational Session will address : What is Human error ? How to perform a failure investigation ? What Methodology should be followed to determine a root cause? What documentation is required to support a root cause? What are the risks and their impact on the organization? Can only training be an acceptable CAPA ? What should be the role of Senior management ? Importance of trending Impact of Quality culture Importance of Reward and recognition
Dr Pareshkumar Dave
The webinar will introduce the Indian Patent Act 1970 with brief history of the Indian patent regime.
Pharma companies generate vast amounts of data, but how much of that data is readily available to make decisions when releasing the products to market? This webinar will discuss various aspects of Digitalization of Data.
This webinar will give an introduction to QbD concept and will explain with a case study how this concept could be implemented during freeze-drying cycle development and introduce the latest approach for construction of the process design space. This Educational Session will cover
QTTP , Product Design , Risk Assessment
Overview of QbD Procedures, Heat & Mass Transfer in Freeze drying, Case study with step by step implementation of & online tools for calculation.
This training is intended to provide guidance to the audience on the pharmaceutical use of different grades of water from a European regulation perspective.
Objectives of the Webinar Introduce the participants the data integrity controls based on Recommendation for Key Management, Part 1: General (SP 800-57 Part 1 ). Understand the importance of CSV and data integrity when using a cloud-based infrastructure.
Daniel J. Roberts
This webinar will discuss some best practices in an open forum for responding to Form FDA 483, Inspectional Observations, warning letter responses and other regulatory compliance queries.
Failure mode effect analysis (FMEA) risk priority number (RPN) scores have traditionally been used to quantify risks for users, designs, and processes. An alternative to the RPN is the action priority (AP) table.This webinar will focus on An Alternative to FMEA RPN Scores by introducing the concept and utilization of the action priority (AP) table.
The presentation will work through the critical thinking and understanding of business process, system Lifecycle and data lifecycle needed to successfully validate a system for its intended use.