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Quality by design

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.  

Challenges in Disinfectant Coupon Testing

Jim Polarine & Dan Kline 

This presentation covers current debates in the industry regarding disinfectant coupon testing.

Design of Pre-Use Post Sterilization Integrity test

Somasundaram G

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.

Thermal Val of Sterile Process with Wired & WirelesS TECH

Dennis Plante

This presentation will cover following :

1.Validation Applications

2.Basic Operation

3.Sensor Technology

4.Temp Range  / Accuracy

5.Ease of Use / Sensor Placement

6.Pre calibration and Post verifications

7.System / Operator Risks

8.Cost of Ownership

Data & Digital adaptation in Pharma Quality Operations

Dr. Gurpal Singh

This presentation will provide examples, future opportunities and challenges in adaptation of data & digital solutions in Quality operations.  

CLEANING VALIDATION Detergent Chem & regulator expectation

Thomas Altman 

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.

Reg. Req - Cleaning & Disinfection of Controlled Mfg Area

Matt Cokely

This presentation reviews the regulatory requirements and ‘best practice’ recommendations for cleaning and disinfection of controlled manufacturing areas. 

Rouge Monitoring

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.

How to Trend & Analyze EM Data

Sheba Zaman & Vivien Santillan

This presentation will have two parts 

Part 1: EM Trending Requirements

Part 2: Trending for Root Cause Analysis

Cleaning Validation - Hot Topics

Thomas Altman 

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 Draft Annex 1 – Reach the Required Level of QRM

Magnus Stering

The New Annex 1 – Reach the Required Level of QRM Before Being Inspected

Determination of Appropriate GMP's for Excipients

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.

CLEANROOM COST, QUALITY & ENVIRONMENTAL SUSTAINABILITY

Keith Beattie 

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.

Investigating Endotoxin Contamination in Water Systems

Dr. Tim Sandle

This webinar will present various aspects of investigating endotoxin contamination in pharmaceutical water systems

Sanitisation & Biofilms in Pharmaceutical Water Systems

Stephan Newman 

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. 

Cleaning Validation - Regulatory Guidelines

Thomas Altman 

This webinar summarises the global regulatory guidelines leading to all the changes for cleaning and its validation within the pharmaceutical industry. 

CONSIDERATIONS FOR DESIGN & QUALIFICATION OF SINGLE USE SYS

Chris smalley & Dharti Pancholi

This Webinar provides guidance on the elements of selection and evaluation of Single-Use systems or components.

PAPERLESS CQV AND BASELINE GUIDE 5

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.

WATER SYSTEM VALIDATION

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.

QRM based Commissioning and Qualification

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.



The information collected when you register for a webinar will not be shared with any organization and will not be used for any commercial purposes. We follow the provisions of Indian Information Technology Act  to protect your data. 

pbpwindia@gmail.com

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