David R. Schoneker, Prof Brian Carlin & Dr. Chris Moreton
The Webinar will include a review of the IPEC QbD Guide on product development and life-cycle management.
Jim Polarine & Dan Kline
This presentation covers current debates in the industry regarding disinfectant coupon testing.
In this session the speaker will cover the contents of refreshing Filter integrity test & Filtration line design for pre-use integrity test (PUPSIT). We will also be covering the Regulatory overview, Current practices, filter masking study & different options available for implementing PUPSIT.
This presentation will cover following :
4.Temp Range / Accuracy
5.Ease of Use / Sensor Placement
6.Pre calibration and Post verifications
7.System / Operator Risks
8.Cost of Ownership
Dr. Gurpal Singh
This presentation will provide examples, future opportunities and challenges in adaptation of data & digital solutions in Quality operations.
The objective of this presentation is to understand what is currently expected to facilitate a state-of-the-art cleaning validation. This should give the participants also a better understanding of the risk-based cleaning validation approach.
This presentation reviews the regulatory requirements and ‘best practice’ recommendations for cleaning and disinfection of controlled manufacturing areas.
Dr. Nissan Cohen
In this this webinar you will learn about rouge, its development, possible liabilities for pharmaceutical products, science-based rouge monitoring, rouge limit determination, and the value of data to refute QC/QA misunderstandings about rouge and their insistence on frequent derouging and passivation.
Sheba Zaman & Vivien Santillan
This presentation will have two parts
Part 1: EM Trending Requirements
Part 2: Trending for Root Cause Analysis
This presentation will focus on the recent hot topics, such as moving from manual cleaning to an automated process, visual inspection and visual clean evaluations after cleaning.
The New Annex 1 – Reach the Required Level of QRM Before Being Inspected
David R. Schoneker
This webinar will present the expectations of International regulators like EMA, FDA and others about the responsibilities that pharmaceutical users have when qualifying their suppliers and determining the appropriate GMPs and controls for the excipients they use in their drug products.
In this webinar, it will be shown how quality, efficiency and costs are related and how most manufacturing clean rooms can be improved so that they deliver high quality environments, safely and efficiently, with significant cost reduction.
Dr. Tim Sandle
This webinar will present various aspects of investigating endotoxin contamination in pharmaceutical water systems
In this webinar various sanitization concepts and why these are necessary to avoid biofilms are discussed. A brief overview on biofilms and some examples of biofilms contamination are also presented.
This webinar summarises the global regulatory guidelines leading to all the changes for cleaning and its validation within the pharmaceutical industry.
Chris smalley & Dharti Pancholi
This Webinar provides guidance on the elements of selection and evaluation of Single-Use systems or components.
Joon Leong & Sarah Grogan
In this webinar, understand the key principles of the ISPE's Baseline Guide Volume 5, how to use paperless validation software to embed its best practices.
Nissan Cohen & Nick Haycocks
About the webinar
Water is the most widely used substance, raw material or starting material in the production, processing and formulation of pharmaceutical products. The presentation will provide an overview a process for the Commissioning and Qualification of a WFI system following the approach described in the baseline guide, and discuss how the use of instrumentation can be integrated into the approach.
Chip Bennett, PMP & Nathan Temple
his webinar discusses the current industry transition of principle ownership of process manufacturing performance verification from Quality/Validation to Engineering – a transition that empowers both Engineering and Quality with the tools to deliver true Quality by Design, resulting in improved product quality (patient safety) and increased speed to market.