This webinar is about the FDA's regulation of its bioresearch monitoring program.
Online PR News – 29-June-2015 – Fremont – Compliance4All announces webinar on the topic, “Introduction to Bioresearch Monitoring” on July 30. This webinar is about the FDA's regulation of its bioresearch monitoring program.
Fremont, CA: Compliance4All, a provider of cost-effective regulatory compliance trainings for a wide range of regulated industries, will organize a webinar on July 30. Thomas E. Colonna, a senior regulatory consultant, will be the speaker at this seminar. The topic of this webinar is “Introduction to Bioresearch Monitoring”.
About the webinar:
FDA's Bioresearch Monitoring (BIMO) Program is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research.
For more information or to register for the webinar, please click here.
The BIMO Program was established in 1977 by a task force that included representatives from the drug, biologic, device, animal drug, and food areas. Subsequent regulations such as 21 CFR Parts 312 and 314, 21 CFR Parts 511 and 514, 21 CFR Part 812, and 21 CFR Part 814 were added to strengthen it.
These regulations establish specific responsibilities of sponsors towards ensuring that: (a) clinical studies are properly conducted while being submitted to the FDA, and (b) the rights and welfare of subjects involved in clinical studies are adequately protected. The speaker at this webinar will talk about the specific responsibilities of sponsors of clinical studies and their obligations as stated in these regulations.
About the Speaker:
Dr. Thomas E. Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics, medical device software, and biotechnology-based products. Dr. Colonna’s consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia.
Compliance4All (http://www.Compliance4All.com/) is a specialized offering from NetZealous, a Fremont, CA-registered organization. It is a source for a wide range of professional trainings, compliance trainings and consulting for the regulated industries. Compliance4All offers a broad range of high quality, affordable regulatory and compliance-related services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.
Many professionals in the various areas in which Compliance4All offers its trainings have benefited from the vast experience of its well-known speakers, who are reputed globally in their respective fields.