If an organization in an FDA-regulated industry has to show compliance with its systems; the most effective way for it is to think the way the FDA does. This is the right approach to getting its compliance requirements right.
FDA inspections can result in anything going all the way up to Warning Letters, seizures, injunctions, prosecutions, or recalls or consent decrees if serious violations are discovered at inspections. How does one inculcate the FDA line of thinking on compliance? Organizations need to first get an understanding of what the FDA looks for and keep these in compliance.
The core of all compliance activity is possession and demonstration of control over the company’s Quality System. When an organization shows this using the subsystem approach; it gives the FDA fewer opportunities to cite minor deviations from the quality system regulation. This is the basis to avoid being cited for more serious systemic deviations from the regulation.
Gaining understanding through training
Proper training on these aspects goes a long way in helping organizations steer clear of issues that give an opportunity for the FDA to take these actions. A two-day seminar from GlobalCompliancePanel, a well-known provider of professional trainings in the regulatory compliance area, will be of immense value in helping professionals get a clear idea of how to get their compliance requirements right.
Just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900523 to learn about the ways of getting into the FDA’s line of thinking on compliance. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
The Director of this seminar, David Dills, Global Regulatory Affairs & Compliance Consultant, who has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services, will offer a clear understanding of all the critical components of dealing with an FDA inspection, such as:
FDA History, Inspectional Strategy and Techniques
- Managing the Inspection and State of Readiness
- Responding to FDA Inspectional Observations (483s)/Warning Letters
- Mock Inspections
- Compliance Program 7356.002, Drug Manufacturing Inspections and other Compliance Programs Device Manufacturing Inspections
- IOM (Investigations Operations Manual)
- RPM (Regulatory Procedures Manual)
- Field Management Directives
- Inspection Technical Guides and official documents used as reference material for investigators and other FDA personnel
Warning Letter and Notice of Violation Responses/Communicating with FDA
- Strategy and Remediation Implementation
- Liaison with FDA to ensure Close-out
- Effective Responses
State of Readiness/Practice/Mock Inspections
- Prepare for “real” inspections by being ready and not caught off guard
- Practice Sessions and Dress Rehearsals on Day Two