Subject: QA/QC

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

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

Designing, Development, Drafting, Processing and Approval of An Effective and Compliant SOP or STM 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… Continue reading Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements

Cleanroom, Microbiology and Sterility Assurance Practices

This intensive, 12- Hour 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… Continue reading Cleanroom, Microbiology and Sterility Assurance Practices

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

Navigating the Stability Universe

There is a universe of individuals, departments, and contract organizations outside the direct control of the Stabilitarian which interact with the stability process in ways that can boost or hinder the success of the program. Some of these are obvious while others go virtually unrecognized, yet members of both can impact us severely and deserve… Continue reading Navigating the Stability Universe

Protein Formulation and Stability

Many of the new molecules being developed by pharmaceutical and diagnostic discovery groups are biologically based, including monoclonal antibodies, proteins, enzymes, etc. Unlike small molecules, these products are much more sensitive to the normal stresses that a product encounters both over the shelf life of the product and during the manufacturing process. Both the formulation… Continue reading Protein Formulation and Stability

Auditing Stability Programs: How to Ensure a Compliant Program

A significant number of 483’s and Warning Letters related to the stability function is proof that not all companies have an adequate program in place. Since regulatory requirements and guidance’s provide only a general picture of expectations for stability programs, much interpretation is left up to individual companies. A better understanding of regulatory expectations and… Continue reading Auditing Stability Programs: How to Ensure a Compliant Program

Cleaning Validation: Best Practices to Implement an Effective and Compliant Process

Cleaning Validation is one of the many GMP requirements critical to the production of a drug product or medical device. Unfortunately, product recalls due to inadequate cleaning still occur indicating that implementation of an effective and compliant program is lacking in some companies. Because costly regulatory actions can have a significant negative impact on a… Continue reading Cleaning Validation: Best Practices to Implement an Effective and Compliant Process

Basic Principles of Cleaning Validation in the Pharmaceutical Industry

This 12-hour accredited ON DEMAND training course, will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling… Continue reading Basic Principles of Cleaning Validation in the Pharmaceutical Industry