Meet Robert Perks & Last Call for CAV/Smoke Studies Webinar

Welcome to the June edition of our newsletter! We're excited to start this month with a fresh batch of PV news and industry insights to share.

As we head into the warmer months, we're eager to bring you the latest updates on our projects, industry trends, and valuable tips to keep you informed and inspired. Thank you for being a part of our community!

Welcome Robert Perks to the Performance Validation Team

We are excited to announce that Robert Perks has joined Performance Validation as our new Digital Solutions Director. This position expands our automation and CSV services, including IT CSV, Process Automation, paperless validation, and digital transformation initiatives.

Robert brings over 21 years of experience in the pharmaceutical industry, with a background in manufacturing automation, validation, and digital transformation. He has held significant roles at Baxter International, Werum America Inc., Cognizant, and PQE Group.

At Baxter, Robert managed a team that developed a comprehensive Manufacturing Tracking & Control System. As VP of Operations for Werum America (now Körber Pharma), he led a team delivering MES platforms to pharmaceutical manufacturers. At Cognizant, he implemented various digital transformation projects for leading pharmaceutical companies.

Robert is actively involved in the International Society of Pharmaceutical Engineers (ISPE) and has held numerous leadership positions, including Chair of the 2022 Annual Meeting. He also contributes to the ISPE GAMP MES Steering Committee and other industry groups.

Robert holds an MSc in Management and a BSc in Control Engineering from Sheffield Hallam University (UK). He is a Chartered (Professional) Engineer in the UK and Europe.

Please join us in welcoming Robert to the Performance Validation team!

Join Us For Our Upcoming Webinar on Critical Airflow Visualization / Smoke Studies

Join us on Tuesday, June 4th for our webinar designed for pharmaceutical manufacturing professionals focusing on the execution and significance of smoke studies in aseptic environments.

This webinar is a must-attend event for anyone involved in pharmaceutical manufacturing, quality assurance, and compliance, offering both foundational education and advanced strategies.

Speaker: Dalton Pierson, Principal Validation Specialist and Smoke Study Subject Matter Expert

INDUSTRY NEWS

FDA wants to prevent manufacturing stoppages during inspections

The US Food and Drug Administration (FDA) is piloting a program to enhance communication between drugmakers, investigators, and its drug shortage team during inspections to prevent facilities from unnecessarily shutting down and potentially contributing to shortages of essential drugs.

FDA issues final guidance clarifying 'remanufacturing' for devices

The U.S. Food and Drug Administration (FDA) has issued final guidance to provide the medical device industry clarity on the definition of "remanufacturing" for reusable devices needing maintenance or repair.

RECENT ARTICLES

Commissioning, Qualification, and Validation (CQV): Navigating Regulatory Landscapes

In pharmaceutical and medical device manufacturing, the concepts of Commissioning, Qualification, and Validation (CQV) form the backbone of ensuring that equipment, systems, and processes operate as intended, consistently producing high-quality products.

These activities are not just operational necessities; they are stringent regulatory requirements designed to safeguard patient safety.

With a landscape governed by international standards such as ISO 9001, GAMP 5, and regulatory bodies including the FDA (Food and Drug Administration) and EMA, navigating CQV processes can be complex.

How the Right Validation Vendor Can Accelerate Your Medical Device’s Journey to Market 

In the highly regulated and competitive world of medical device manufacturing, getting your product to market swiftly and safely is paramount. This journey is fraught with complex regulatory requirements designed to ensure product safety and efficacy.

At the heart of navigating this challenging landscape successfully is the process of validation – a critical step that verifies the medical device manufacturing process meets all your quality system and regulatory requirements. This is where choosing the right validation vendor becomes not just a decision but a strategic move in your product’s journey to market.

As always, we aim to keep you in the loop with valuable insights and industry news to inspire and inform you. But, we're all about improvement too! We genuinely value your feedback, so please take a moment to click the link below and let us know how we can make this newsletter even better.