Subject: QA/QC

CMC Writing and Submission Strategies

The CTD is the basis of drug, biologic, and drug-device combination registration applications. A proper understanding of CTD writing strategy and health authority expectations can greatly aid a company in gaining approval. With the prerequisite complete, this accredited training, will provide in-depth instruction on Chemistry, Manufacturing, and Controls (CMC) requirements and review processes for clinical… Continue reading CMC Writing and Submission Strategies

Annual Product Reviews/Product Quality Reviews

Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU, and Canada. The purpose of the annual product quality review course is to educate the participant in the regulatory requirements for the FDA Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as… Continue reading Annual Product Reviews/Product Quality Reviews

How to Conduct Robust Root Cause Investigations for CAPA

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of a sub-standard product, or product recall. Furthermore, costly… Continue reading How to Conduct Robust Root Cause Investigations for CAPA

GMP in a Nutshell

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

Introduction to Pharmaceutical Quality Management Systems

This accredited online training course describes the requirements of an effective, comprehensively designed and correctly implemented Pharmaceutical Quality Systems (PQS) that incorporates Good Manufacturing Practice, Controls, Continuous improvements, and Quality Risk Management. All parts of the PQS should be adequately resourced with competent personnel, suitable and sufficient premises, equipment, facilities, processes, and effective procedures. This… Continue reading Introduction to Pharmaceutical Quality Management Systems

GLP and Quality Assurance

Benjamin Franklin famously said: “Tell me and I forget; teach me and I may remember; involve me and I learn.” This course has been designed with this cogent observation in mind so that each person can get involved in problem-solving and thus learn about how to perform the role of Quality Assurance for laboratories undertaking… Continue reading GLP and Quality Assurance

Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable to avoid costly errors, batch disposal, expensive failure… Continue reading Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

The QbD Toolbox

If you are charged with exploring or implementing a QbD effort within your organization, where do you begin? Available guidance documents do not provide all of the information necessary to effectively implement such a program. Without proper understanding of how to establish QbD, your efforts may fail. This accredited training course presents methods that assist… Continue reading The QbD Toolbox

Pharmaceutical Process Development

This course is designed to provide a basic understanding of the significant process development effort involved in taking an R&D laboratory formulation to commercial production. This course will focus on two main areas: How to develop a pilot process suitable for scale-up to commercial production. Factors to consider during scale-up and technology transfer to take… Continue reading Pharmaceutical Process Development

Writing and Enforcing SOPs: Best Practices for Regulated Industries

Organizations often face challenges when creating and enforcing effective standard operating procedures (SOPs). Poorly written SOPs are a common cause of deficiencies and observations mentioned in 483s and warning letters issued by the FDA. Therefore, companies operating in regulated industries must understand how to organize and present information for the intended audience and purpose. To address… Continue reading Writing and Enforcing SOPs: Best Practices for Regulated Industries