Subject: Compliance

Effective and Compliant Technical Writing

This technical writing training program will offer you an understanding of how the reporting process supports products in research, development, and in the marketplace. The 2.5-hour, accredited ON DEMAND training will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train… Continue reading Effective and Compliant Technical Writing

Computer System Validation and Part 11 Compliance

Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. This 90-minute accredited ON DEMAND training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining… Continue reading Computer System Validation and Part 11 Compliance

Excipients: Compliance with Compendial and GMP Requirements

Excipients often play a critical role in the manufacture of bio/pharmaceuticals and in the formulation of small molecule and biotherapeutic products as well as, enabling delivery of medicines to the patients who need them. Companies that manufacture, distribute and use excipients must meet appropriate quality and regulatory requirements. The General Notices of the United States… Continue reading Excipients: Compliance with Compendial and GMP Requirements

GXP Foundations

GXP are a set of regulations and guidelines that together embody best practices for several key elements of medical product development. Because the regulatory landscape is complex and medical product innovations are both unique and diverse, it can be difficult for sponsors to develop a framework for product development and marketing that is both acceptable… Continue reading GXP Foundations

Proper Batch Record Review for Compliance and Effectiveness

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that… Continue reading Proper Batch Record Review for Compliance and Effectiveness

Designing an Effective Environmental Monitoring Program

Determining a Cleanroom State of Control The importance of designing an effective Environmental Monitoring (EM) program cannot be overemphasized. The data from this program provides an effective measuring tool that determines an effective cleanroom control from a Facility design, validation, implementation, disinfection, disinfectant effectiveness, gowning controls, cleanroom trafficking, aseptic controls, personnel training, and practices. It… Continue reading Designing an Effective Environmental Monitoring Program

Data Integrity Practices for the Laboratory and Beyond

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory… Continue reading Data Integrity Practices for the Laboratory and Beyond

GLP Study Director: How to Deal with GLP, Sponsors, QA and Multi-Site Challenges

Benjamin Franklin famously said: Tell me and I forget, teach me and I may remember, involve me and I learn This intensive 8- hour accredited course has been entirely redesigned with Franklin’s cogent observation in mind so that each person can get involved in problem-solving and thus learn about how to run regulatory studies that… Continue reading GLP Study Director: How to Deal with GLP, Sponsors, QA and Multi-Site Challenges

GMP in a Nutshell: An Introduction to cGMP

“Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current… Continue reading GMP in a Nutshell: An Introduction to cGMP

Computer System Validation: Rules and Tools

Since the 1980’s the FDA and International regulatory agencies have been very concerned about the increased use of computer systems for reporting, clinical trials analysis, and communication. Early validation guidance’s focused on processing and reporting. However, today the industry is dependent on the use of computer systems. Developments in areas such as Artificial Intelligence, computer-controlled… Continue reading Computer System Validation: Rules and Tools