Tuesday, October 20, 2009

Uncle Stephen Misati

http://ivy50.com/blackHistory/story.aspx?sid=10/19/2006

Compliance and Validation Support LLC

Compliance and Validation Support provides a full range of expert consulting services to FDA regulated industries which includes Pharmaceutical, Biotech and Medical Device companies throughout North America. Compliance and Validation Support offers comprehensive knowledge of current regulatory standards, practices and a unique awareness of enforcement policies and activities.

Compliance and Validation Support offers are clients the resources and specialized guidance they need to cost-effectively comply with the policies and regulatory requirements of the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), Health Insurance Portability and Accountability Act (HIPPA), Occupational Safety and Health Administration (OSHA), World Health Organization(WHO), and Environmental Protection Agency (EPA) and applicable state regulatory requirements and registration processes.


Our principle goal is to assist food and drug manufacturers in assuring compliance with current regulatory needs. Our work includes advising or writing concise quality systems or validation protocols. Compliance and Validation Support also performs in-house validation support, review of validation efforts and documentation, writing and review of SOPs, and auditing all areas of manufacturing and research.

Other Compliance & Validation Support principles include:

Conduct business relationships justly, honorably, and with integrity

Puts public safety for are consultants and our clients customer’s service first

Accountable for our actions and stay focused on results.

Accept responsibility for subsequent outcomes


Compliance and Validation Support is a consulting company that specializes in computer validation, cleaning validation, process validation, clean room certification, temperature mapping, process equipment and facility qualification. Our company goal is to ensure that quality is built into the system at every step, and not just tested for at the end, as such validation activities will commonly include training on production material and operating procedures, training of people involved and monitoring of the system while in production.