Subject: QA/QC

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

Basics of Microbiology

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 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Microbiology

Requirements for Aseptic Techniques and Practices

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 Requirements for Aseptic Techniques and Practices

Writing and Enforcing Effective SOPs Basics

The purpose of this accredited training is to equip participants with the necessary skills for writing effective Standard Operating Procedures (SOPs) that support their company’s activities. Throughout the course, participants will learn how to organize and deliver information tailored to the intended audience and purpose, write documents that are clear and easy to read, and… Continue reading Writing and Enforcing Effective SOPs Basics

Effective Complaint Handling Procedures

This accredited training will provide attendees 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 manufacturer hopes to… Continue reading Effective Complaint Handling Procedures

Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements

Designing an effective Standard Operating Procedure (SOP) and Standard Test Method (STM) is the pre-requisite to complying with the different regulations guiding the manufacturing and testing of products. A well-established procedure and test method improves the numbers of manufacturing, testing and personnel deviations which indirectly affects the quality and life cycle process of a manufactured… Continue reading Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements

Cleanroom, Microbiology and Sterility Assurance Practices

This intensive course provides attendees a comprehensive knowledge about the A-Z of Sterility Assurance which is based on regulatory requirements, FDA guidance, compliance expectations, and industry practices. Key elements of sterility assurance and contamination control starts from creating a robust and compliant cleanroom design, validation/qualification, operations, environmental monitoring program requirements, microbiological processes/methodology, cleanroom cleaning/disinfection, trafficking, gowning… Continue reading Cleanroom, Microbiology and Sterility Assurance Practices

Good Clinical Practice

The concept of Good Clinical Practice (GCP) goes beyond a mere collection of guidelines and complex, challenging language to interpret. It encompasses the culmination of years of progress and revelations in the field of medicine, encompassing both well-intentioned and misguided human decisions, along with consequences that range from unfortunate to truly horrifying. GCP serves as… Continue reading Good Clinical Practice

Good Laboratory Practice for Nonclinical Laboratory Studies

Complying with the principles of Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) is of utmost importance to ensure the reliability and credibility of study data. Nonclinical laboratory studies, also known as preclinical studies, play a vital role as a prerequisite for demonstrating the safety and essential performance aspects of products intended for human use.… Continue reading Good Laboratory Practice for Nonclinical Laboratory Studies