Nd Admin

New Modalities & Emerging Technologies For Biologics Production

9 Takeaways from ‘Repairing a C&Q Program With Digitization’

Leave a Comment / Blog, Digitalization, Paperless Validation / Nd Admin

At Validate 2024 in Berlin, Pierre Winnepenninckx delivered a compelling talk titled “Repairing a C&Q Program with Digitization,” offering deep insights into how companies can enhance their Commissioning and Qualification (C&Q) processes by embracing digital tools. Pierre’s experience of over 23 years in the C&Q space has led him through multiple roles and challenges in

9 Takeaways from ‘Repairing a C&Q Program With Digitization’ Read More »

Positive Impacts and Challenges of Digitalization in the Pharmaceutical Industry." The infographic highlights several key benefits and challenges brought about by digital transformation.

Impact Of Digitalization on the way of work in the Pharmaceutical Industry

1 Comment / Blog, Digitalization / Nd Admin

Digitalization is the process of using digital technologies to transform business processes, services, or models to adapt to the digital age. It involves integrating digital technology into various aspects of an organization’s operations, often with the goal of improving efficiency, effectiveness, and overall performance. Digitalization has significantly impacted the way people work across various industries

Impact Of Digitalization on the way of work in the Pharmaceutical Industry Read More »

Isolator Decontamination via vaporized Hydrogen v12no-deviation-pharmaceutical

Isolator decontamination via Vaporized Hydrogen Peroxide

1 Comment / Blog / Nd Admin

As regulatory standards evolve, the implementation of select technologies becomes vital to meet the requirements of cleanroom environments. In the latest update to the EU GMP Annex 1 in 2022, isolators have emerged as the preferred technology in aseptic fill finish processes to ensure ideal cleanroom conditions and minimize microbial contamination associated with human interventions.

Isolator decontamination via Vaporized Hydrogen Peroxide Read More »

7 Key Lessons from the Field on AI and Pharma Document Silos

Post-approval of CMC changes under FDA, EMA and HSA guidance

2 Comments / Blog / Nd Admin

Before any drug intended for human use or chemical and biological products can be distributed and utilized, it must undergo approval by regulatory agencies to ensure its safety and efficacy. This initial step involves the submission of a new drug application to pertinent regulatory bodies, notably the United States Food and Drug Administration (FDA) for

Post-approval of CMC changes under FDA, EMA and HSA guidance Read More »

Overview of key insights on ensuring pharmaceutical manufacturing sterility and safety, highlighted from 'The Aseptic Process Validation' webinar.

6 Takeaways from ‘The Aseptic Process Validation – A Risk-Based Approach’ Webinar: Ensuring Sterility and Safety in Pharmaceutical Manufacturing

1 Comment / Blog / Nd Admin

In the ever-evolving pharmaceutical industry, ensuring the quality of products through rigorous aseptic process validation is paramount. This article, inspired by the insights from the “Aseptic Process Validation – A Risk-Based Approach” webinar featuring Shanshan Liu and Laura Noone of No deviation, dives into the critical aspects of Aseptic Process Validation. With a focus on

6 Takeaways from ‘The Aseptic Process Validation – A Risk-Based Approach’ Webinar: Ensuring Sterility and Safety in Pharmaceutical Manufacturing Read More »

c and q lifecycle pharmaceutical industry no deviation

Defining Requirements in the C&Q Lifecycle

1 Comment / Blog / Nd Admin

The ISPE Baseline Guide Volume 5: Commissioning and Qualification Second Edition proposes an integrated C&Q approach that aims to make the C&Q process compliant, efficient, and cost-effective. The key facets of this approach are as follows: Using a System Risk Assessment (SRA) to identify Critical Design Elements (CDEs) that need to be qualified Using properly

Defining Requirements in the C&Q Lifecycle Read More »

New Modalities & Emerging Technologies For Biologics Production

9 Takeaways from ‘Repairing a C&Q Program With Digitization’

Impact Of Digitalization on the way of work in the Pharmaceutical Industry

Isolator decontamination via Vaporized Hydrogen Peroxide

7 Key Lessons from the Field on AI and Pharma Document Silos

Post-approval of CMC changes under FDA, EMA and HSA guidance

6 Takeaways from ‘The Aseptic Process Validation – A Risk-Based Approach’ Webinar: Ensuring Sterility and Safety in Pharmaceutical Manufacturing

Defining Requirements in the C&Q Lifecycle

8 Takeaways from Digital Pharma Panel: Challenges to Digital ‘Emancipation’

Revolutionizing Validation Processes: VEQTOR’s Out-of-the-Box Solution for Dechra Pharmaceutical PLC

SITEMAP

STAY CONNECTED

FOLLOW US

CONTACT INFORMATION

Copyright © 2024 No deviation Pte Ltd. All rights reserved.