Training Doyens

Drugs produced in the pharmaceutical industry go through extensive quality controls to ensure a level of safety for the consumer or patient and yet when we talk about the process and quality controls in medical cannabis production, there is still a lot to learn. Our upcoming webinar discusses the recent federal government position on ending cannabis prohibition nationwide and what the regulations mean for GMP regulated industries. The webinar covers the following key areas: ·          HR policies and the new cannabis era (labor law challenges) ·          Common quality failures and threats ·          Challenges with the regulation of plant-based product LEARNING OBJECTIVES • Recent federal government position on ending Cannabis prohibition nationwide • FDA position on CBD and other cannabis derived products • Background from a regulatory standpoin...

Drugs produced in the pharmaceutical industry go through extensive quality controls to ensure a level of safety for the consumer or patient and yet when we talk about the process and quality controls in medical cannabis production, there is still a lot to learn. Our upcoming webinar discusses the recent federal government position on ending cannabis prohibition nationwide and what the regulations mean for GMP regulated industries. The webinar covers the following key areas: ·          HR policies and the new cannabis era (labor law challenges) ·          Common quality failures and threats ·          Challenges with the regulation of plant-based product LEARNING OBJECTIVES • Recent federal government position on ending Cannabis prohibition nationwide • FDA position on CBD and other cannabis derived products • Background from a regulatory standpo...

OVERVIEW When we discuss growing, producing, and manufacturing medical cannabis , we must think of it as a medicine. Medicine by definition, it is a substance intended to assist you with a medical condition, to help you feel better and not harm you. Drugs produced in the pharmaceutical industry go through extensive quality controls to ensure a level of safety for the consumer or patient. Yet when we talk process and quality controls in medical cannabis production, there is still a lot to learn. With all new events the FDA has stated that it “recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD.” However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket. In order to start understanding what it...

Data integrity is the completeness, accuracy and consistency of data, regardless of the format in which it is generated, retained or used.  Maintaining the integrity of data pertaining to GMP activities is very important for maintaining compliance with the regulations. Best practices for maintaining data integrity not only encompass the Quality Control (QC) data but also the data which is generated by other activities like manufacturing, validation, packaging, materials management, facilities management and more. An effective way of maintaining data integrity involves risk-based and holistic assessment of the systems that store the data related to GMP operations, and include manual, electronic and hybrid systems. Here are some of the best practices for maintaining GMP data integrity: Understanding Part 11 Requirements The first step of working towards data integrity includes identifyingand understanding the Part 11 requirements applicable to electronic records and signat...

OVERVIEW In this 90 minute webinar attendees will gain an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in the pharmaceutical, biologics, and med device facilities. Other objectives include inspection authorities and processes including 483s, warning letters, recalls, and other potential actions, inspection processes, use of mock audits required documentation, formats, archiving, as well as how to respond to inspection and audit results. WHY SHOULD YOU ATTEND One should attend this webinar to increase one’s knowledge ofFDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. One will gain a better understanding of the parameters, approaches, and concerns of FDA inspectors. One will also gain a more in depth understanding of how to prepare for unannounced FDA audits and inspections. GMP Training AREAS COVERED The insp...