This course provides a basic understanding of cleaning and sanitation for dietary supplement facilities. Participants will learn the importance of sanitary facility design, how to build contamination prevention mitigation into the construction of the plant, and how to write a compliant environmental monitoring plan. You will learn what SOPs are required for general facility cleaning and sanitation. At the conclusion of this training, participants will have an understanding of what is required in order to have a compliant cleaning and sanitizing program. At the conclusion of this training participants will have an understanding of what is required in order to have a compliant cleaning and sanitizing program: • Discuss relevant terminologies • Review Personnel hygiene and training requirements • Discuss Facility cleaning and sanitizing • Latest advice from the CDC and WHO • Contamination prevention mitigation • Environmental monitoring • Development of Cleaning & Sanitizing Methods Please note there are two recordings for this session. Instructor: Norm Howe A PDF of the presentation will not be not be distributed for this recording. You'll have access to the recording for 15 days once you complete your registration.  Certificate of participation are not issued for recorded courses​. Read More

The purpose of this course is to provide an overview of current good CSV practice along with some practical advice about how to achieve good outcomes in a cost-effective and resource-efficient way. Read More

Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements.  This eLearning course is aimed at anyone working in the Pharmaceutical Industry and provides an overview of what is meant by data integrity, what needs to be considered during documentation completion, review and approval and how to keep your data complete, consistent and accurate throughout the data lifecycle. Read More

Module 2 of our Data Integrity Series This course (module 2) will build on the key messages of module 1 and go beyond the basics.  It will look at some more specialised or particular aspects of this topic which has such wide ranging impact.  This course consolidates knowledge and experience of 11 years work from an ex MHRA Inspector.  Management and the Quality Unit need to have a deeper understanding of Data Integrity to give them the confidence to get involved and this module is designed to highlight the known weaknesses in company systems.   This course is module 2 of our Data Integrity series of courses.  We would suggest that prior to this course you take module 1, Data Integrity: Overview and Documentation Completion, Review and Approval course.   Read More

Module 3 of our Data Integrity Series Data Integrity Module 1, Basics of Data Integrity addressed what everyone needs to know for this essential topic.  Module 2 went beyond the basics focusing on the technical details for subjects such as auditing and computer systems management. In this third Module we build on your essential knowledge to understand what the Senior Management should ensure is in place, in use and effective. Read More

The FDA is aware of some confusion surrounding the guidance, Deciding When to Submit a New 510(k) for a Change to an Existing Device. As such, FDA has worked diligently over the past few years to enhance predictability, consistency and transparency while maintaining a “least burdensome approach.” The new updated guidance provides greater detail of the regulatory framework, policies and practices underlying FDA’s decision-making process and provides much needed clarity for industry on FDA’s expectations. In this course we walk through these changes and discuss how to determine when to submit. Read More