Subject: GMP

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

GMP Laboratory Control Professionals Certification Program

In their own Guide to Inspecting Quality Control Laboratories, the FDA states: 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. Accurate, reliable, and meaningful laboratory data is… Continue reading GMP Laboratory Control Professionals Certification Program

Sterilization Professionals Certification Program

In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of… Continue reading Sterilization Professionals Certification Program

GMP Professional Certification Program

Earn Your GMP Professional Certification Cobblestone’s GMP Professional Certification Program will provide you with the necessary orientation and understanding of the USA FDA’s Current Good Manufacturing Practice for pharmaceutical products. You will be trained in the understanding and interpretation of the FD&C Act, the cGMPs, the FDA Guidance Documents, and FDA’s recent observations in FD… Continue reading GMP Professional Certification Program

FDA Inspection Readiness Certification Program

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading FDA Inspection Readiness Certification Program

Sterile Products

Parenteral product development and aseptic manufacturing can be intimidating to people new to the topics. The approach to formulation and process development is substantially different than for oral and topical medications. Product development and manufacturing must consider how all of the manufacturing processes align to ensure chemical, physical, and microbiological stability with particular attention to… Continue reading Sterile Products

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

David E. Wiggins

David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation, and method transfer. Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for method optimization, method validation,… Continue reading David E. Wiggins