Subject: Compliance

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

Good Documentation Practices for Laboratory Records

In FDA’s Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93), it is stated The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Good documentation practices are expected… Continue reading Good Documentation Practices for Laboratory Records

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

FDA Regulation of Artificial Intelligence/ Machine Learning

What Can and Cannot Be Done Artificial Intelligence/ Machine Learning (AI/ML) will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidances for years, however, AI/ML programs fall outside the scope of these regulations and guidances. This happens because FDA approves the… Continue reading FDA Regulation of Artificial Intelligence/ Machine Learning

FDA Inspection Essentials: Key Dos and Don’ts

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 FDA Inspection Essentials: Key Dos and Don’ts

Effective Complaint Handling Procedures

This accredited 90-minute training will provide attendees with an understanding of the rules and regulations guiding complaint handling and complaint files within the life science industries. Per 21 CFR Part 820.198, Each manufacturer shall maintain complaint files, establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. While a product… Continue reading Effective Complaint Handling Procedures

Good Clinical Practice: When Good Studies Go Bad

Good Clinical Practice (GCP) is more than a stack of guidelines and pithy, difficult to interpret language. It is the result of decades of advancement and discovery in medicine; of human decisions both well-intentioned and not; and of consequences ranging from unfortunate to horrific. GCP is a codification of the very hard lessons we have… Continue reading Good Clinical Practice: When Good Studies Go Bad

Good Laboratory Practice for Nonclinical Laboratory Studies

Adherence to Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) is critical for ensuring the quality and integrity of study data. Nonclinical laboratory studies (sometimes referred to as preclinical studies) are crucial, and prerequisite, for demonstrating the safety and key aspects of performance of products intended for human use. In this 90-minute accredited ON DEMAND… Continue reading Good Laboratory Practice for Nonclinical Laboratory Studies