Subject: Compliance

GLP 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

CAPA: 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

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

Current Good Tissue Practices (cGTP): Establishing and Maintaining FDA Compliance

“All organizations that recover, screen, test, process, store, label, pack and/or distribute Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) must adhere to the current Good Tissue Practice regulation (cGTP), 21 CFR Part 1271 Subparts D. Set by US FDA, this regulation can appear to be a confusing collection of legal requirements for the… Continue reading Current Good Tissue Practices (cGTP): Establishing and Maintaining FDA Compliance

GMP 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

GMP Professional Certification

The GMP Professional Certification Program will provide the necessary orientation and understanding of the USA FDA’s Current Good Manufacturing Practice for pharmaceutical products. The certification program will cover techniques and practices to ensure compliance with these regulations including manufacturing, packaging, holding, distribution and the laboratory. It will provide a practical application of the cGMP on… Continue reading GMP Professional Certification

Writing Effective Regulatory, Medical and Technical Documents

The approval of a drug product or medical device regulatory submission hinges in large part on the quality of the documents submitted to regulatory authorities. Thus, writing accurate, concise, well-referenced and clear technical documents is critical for a company’s business success. Effective writing is a skill that must be constantly refined to produce these quality… Continue reading Writing Effective Regulatory, Medical and Technical Documents

Quality Management and Compliance in the Pharmaceutical and Related Industries

Under the global regulator-based inspection approach, the Quality system is one that is routinely audited. Quality issues are a huge factor in inspection observations leading to recalls for drugs, biologics, and medical devices. This indicates that not all companies are meeting current GMP expectations. Clearly a better understanding is needed to overcome this trend and… Continue reading Quality Management and Compliance in the Pharmaceutical and Related Industries

Good Laboratory Practices (GLP)

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 Good Laboratory Practice (GLP) Regulations. Overall, the main intent of… Continue reading Good Laboratory Practices (GLP)

Regulatory Compliance for the Personal Care Products Industry

“Since in many countries, Personal Care products do not require Health Authority review and approval prior to marketing, there is often confusion about what product claims can be made, what labeling is required, and what ingredients cannot be used. Without knowledge of the regulations in each country, non-compliant product is often detected by Health Authorities… Continue reading Regulatory Compliance for the Personal Care Products Industry