Subject: Regulatory

FDA Case Scenarios

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading FDA Case Scenarios

Conducting Successful Quality Audits: Best Practices for Managing Inspection Situations

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Conducting Successful Quality Audits: Best Practices for Managing Inspection Situations

Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

Managing Effective Regulatory Inspections and 483 Responses

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Managing Effective Regulatory Inspections and 483 Responses

Computer System Validation: A Regulatory Overview

The ever‐increasing use of computers within the life science industries draws the attention of the FDA and international regulatory agencies. In recent years we have moved from simple record-keeping systems to computer‐controlled processing, manufacturing, devices, and inventory systems. As we look forward to the increasing use of artificial intelligence, we will require increasingly sophisticated computers,… Continue reading Computer System Validation: A Regulatory Overview

Introduction to Product Claims Development and Support

Differentiating claims are often key to successful OTC and CPG products. Consumer awareness of products is based on these labels and advertising claims that need to be both consumer meaningful and grounded in adequate scientific support. Agencies like the US-FDA, the Federal Trade Commission (FTC), and even TV networks have established requirements and guidelines on… Continue reading Introduction to Product Claims Development and Support

Intellectual Property Law Basics: For Managers, Engineers and Scientists

Intellectual Property (IP) has a significant impact on industrial and commercial ventures, regardless of the organization’s size. Even basic knowledge of IP can prevent missed opportunities and protect against potential risks, particularly during project initiation. Promptly investigating and asking questions can save valuable resources. This accredited training aims to equip participants with a comprehensive understanding of… Continue reading Intellectual Property Law Basics: For Managers, Engineers and Scientists

How to Manage and Prepare for a Pre-Approval Inspections (PAI)

The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Many times, the arrival of a… Continue reading How to Manage and Prepare for a Pre-Approval Inspections (PAI)

Managing Standard Operating Procedures (SOPs) in the FDA Regulated Environment

Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible.… Continue reading Managing Standard Operating Procedures (SOPs) in the FDA Regulated Environment

Handling OOS Test Results and Completing Robust Investigations

It was the Barr Decision in the early 1990s that first coined the term Out-of-Specification (OOS). Since that landmark case, pharmaceutical companies, both drug and biologicals, have had to perform adequate investigations whenever an OOS result was obtained through laboratory testing. In the nearly 30 years since then, FDA continues to cite companies for not… Continue reading Handling OOS Test Results and Completing Robust Investigations