Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are...
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The Importance of Validation
Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities...
Fulfilling Requests During an Inspection
In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting...
How to Find the Perfect Consultant
After an hour-long meeting of highly caffeinated conversations, the executive leadership team woke up this morning creating an Excel list of action items that topped off your inbox. The dreams of last night turned into the demands of the workday today. This Excel list...
Inspection Management Teams for GxP Inspections
Undergoing a GxP-compliance regulatory inspection is a challenge for any company or site staff. Since various individuals, and even multiple departments, participate in inspections, you need a high level of pre-inspection organization and planning. In previous blogs,...
Preparing for an inspection Part I: Building an Inspection Team
Site inspections are regular activities to check and verify your organization's regulatory compliance, safety standards, and more. The FDA, EHS, and the EPA may do inspections and audits virtually or in the field. The FDA tries to inspect each licensed firm every two...
The Importance of First Impressions on Inspection Day
What are you and your team doing to win on inspection day? Preparation for inspections is an ongoing process. You likely have a lengthy checklist of items that must go perfectly on the day of an inspection. However, many inspection readiness teams overlook the...
Effective Risk Management For Medical Devices
Risk Management is your system of management policies, procedures, analysis practices, and monitoring risk. An effective risk management program is an essential element in the life cycle of a medical device. A Hazard is a potential source of harm. A Risk is your...
Quality Assurance (QA) and Quality Control (QC) and Industry 4.0
The biomanufacturing industry is currently undergoing a revolution in how it develops products. The major driving force behind this paradigm shift is known as Industry 4.0. This approach focuses on how to apply predictive modeling, data, analytics, artificial...
Regulatory Series | Part 2 | Manage your Risks with ICH Q9
Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®An effective risk management system is part of your quality management system. Your risk management system will identify the probability that quality issues can arise during your product life cycle....