Online Compliance Training Latest News

OnCourse Learning announced today it has completed its acquisition of Digital University, an online bank and credit union regulatory compliance training expert, to its training portfolio.

This 90-minute presentation will discuss a structured way to mitigate risks with minimum cost. You will learn how to use FMEA to effectively estimate and assess risks in your medical device.

A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug.

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices.

The training will cover DEA record-keeping and security requirements that DEA registrant must comply with when handling controlled substances

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations.

DEA OFFICE OF DIVERSION CONTROL – familiarize the participant with the authority given to DEA when enforcing federal laws and regulations pertaining to controlled substances.

All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices.

This webinar presents a best practices approach for preparing, characterizing and storing cell banks used for GXP analytical and bioanalytical test methods.

This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach).

This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.

This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies

This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines.

The instructor addresses the details of the MDD and includes other significant issues such as the Quality Management System (ISO 13485), Risk Management (ISO 14971), Clinical Evaluation (MDD Annex X), and the role of harmonized standards.

This unique hands-on course will provide attendees with risk and control concepts as well as deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.

"Attendees will recieve a complimentary e-book of " How to write standard operating procedures and work Instructions", published by the Instructor in 2010.The e-book will be send out to attendees after the webinar.

Who will benefit: Quality Control Laboratory Manager Warehousing Purchasing Managers Procurement Managers Laboratory Analyst Cost Accounting