Industry: Biotechnology / Biopharmaceutical

Data Integrity

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 Data Integrity

Complaint Handling Requirements (US)

Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities. 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.… Continue reading Complaint Handling Requirements (US)

Best Practices for Investigation Deviations and Non-Conformances

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 Best Practices for Investigation Deviations and Non-Conformances

Basic FDA GLP Training (Good Laboratory Practice Training)

No drug makes it into human usage without having first been demonstrated safe in animal models. Good Laboratory Practices (GLPs), which grew out of a lack of quality and scientific integrity in toxicology studies conducted in the 1970s, established FDA’s requirements for the conduct of such nonclinical studies. Bioanalytical analyses for GCP-regulated studies are also… Continue reading Basic FDA GLP Training (Good Laboratory Practice Training)

Basic Principles of GCP (Good Clinical Practice)

Good Clinical Practice (GCP) standards, required by the FDA and international regulatory bodies, provide assurance that the data and reported results are credible and accurate, and the rights, integrity, and confidentiality of trial subjects are respected and protected. During this 90-minute, intensive training, participants will obtain a comprehensive overview of the purpose, scope, and legal… Continue reading Basic Principles of GCP (Good Clinical Practice)

Introduction to Lyophilization Technology

This 90-minute course introduces you to the basics of lyophilization and why we lyophilize drug products. Typical approaches to developing a drug product formulation and lyophilization process development will be discussed. At the end of the course, you will be able to identify analytical techniques that are available to characterize drug products. The final goal… Continue reading Introduction to Lyophilization Technology

Managing Conflicting Feedback in Product Development: Including Investors, Advisors, and other Stakeholders (FREE WEBINAR)

As an innovator, you’ve probably been beaten over the head with lean startup and customer discovery methodology (don’t worry, in case this is new for you, we’ll cover it briefly – and better yet – frame it in a way that acknowledges the complexity of the stakeholder ecosystem). But what do you DO with all… Continue reading Managing Conflicting Feedback in Product Development: Including Investors, Advisors, and other Stakeholders (FREE WEBINAR)

An Introduction to Oral Solid Dosage Form: Terminology, Process and Material Basics

The most common pharmaceutical dosage is the oral solid dosage form which includes both tablets and capsules. There are many different ways to manufacture these products starting with the appropriate selection of excipients all the way through the production of the finished product. Ultimately, the successful production of a tablet or capsule is dependent upon… Continue reading An Introduction to Oral Solid Dosage Form: Terminology, Process and Material Basics

Intellectual Property Law Basics: For Managers, Engineers and Scientists

Intellectual Property (IP) in one form or another affects much of industrial and commercial endeavors, no matter the size of the organization. Being aware, at least at a basic level, can help avoid lost opportunities and protect against potential pitfalls, especially at the outset of a project. Timely questioning or fact finding can be beneficial… Continue reading Intellectual Property Law Basics: For Managers, Engineers and Scientists

Basics of Electron Beam Sterilization Process Requirements

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483’s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Electron Beam Sterilization Process Requirements