The research, development, manufacturing, and regulatory approval of new biotechnology and biopharmaceutical products often presents novel challenges for which a background in conventional pharmaceuticals offers little guidance.
To bridge this gap between academic instruction and the real-world complexities of research, development, validation, regulations, processing, and manufacturing, we provide practical, specialized training by industry experts. With ever-changing scientific understanding and government regulations, it’s critical that you have the most current information possible – training with COBBLESTONE ensures you will.
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
Read MoreIntroduction to Pharmaceutical Quality Management Systems
This 90-minute ON DEMAND 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… Continue reading Introduction to Pharmaceutical Quality Management Systems
Read MoreComputer 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
Read MoreGLP and Quality Assurance: Developing a GLP Compliant QA Program
Benjamin Franklin famously said: Tell me and I forget, teach me and I may remember, involve me and I learn. This course has been entirely redesigned 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… Continue reading GLP and Quality Assurance: Developing a GLP Compliant QA Program
Read MoreBasic 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
Read MoreCAPA: A Critical Quality System Requirement
The Role of Corrective Action and Preventative Action in Your Quality System There has been several form 483’s and warning letters being issued to companies by the FDA as it relates to CAPA investigation because of insufficient or incomplete quality systems procedures applicable to corrective action and preventative action programs (CAPA). Addressing an FDA form… Continue reading CAPA: A Critical Quality System Requirement
Read MoreThe QbD Toolbox: Resources That Help New QbD Programs
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 a proper understanding of how to establish QbD, your efforts may fail. This 90-minute accredited training course presents methods… Continue reading The QbD Toolbox: Resources That Help New QbD Programs
Read MoreWriting and Enforcing SOPs: Best Practices for Regulated Industries
“Writing and enforcing effective standard operating procedures (SOPs) can be challenging. Poorly written SOPs are one of the most common causes of deficiencies and observations cited in 483s and warning letters from the FDA. Companies in regulated industries must know how to organize and deliver information for the intended audience and the intended purpose. This… Continue reading Writing and Enforcing SOPs: Best Practices for Regulated Industries
Read MoreQualification and Management of CMOs (Contract Manufacturing Organizations)
Every pharmaceutical company hopes to obtain their desired expectations when it comes to important relationships with their Outsourcing Partners. This intensive course examines the root causes of critical issues that can arise within these relationships which are much broader and deeper than the technical capability to perform a process. This intensive 12-hour, accredited course, examines… Continue reading Qualification and Management of CMOs (Contract Manufacturing Organizations)
Read MoreGMP Laboratory Control Professionals Certification
In their own Guide to inspecting Quality Control Laboratories, 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 critical… Continue reading GMP Laboratory Control Professionals Certification
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