Think like the FDA to get compliance right

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

• SOPs
• Training
• Audits
• 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
• Drafting
• 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

A look into CAPA Investigations

Corrective and Preventive Actions (CAPA) is a method by which organizations take steps to bring about improvements and corrections into their processes. The basic aim of CAPA is to identify the causes of nonconformities or deviances from the processes, practices or products and rectify them to bring them in line with the stated objectives to produce desired outcomes.

Many GxPs have adapted the principles inherent in CAPA. Many ISO standards are created to this effect. The fundamental aim of CAPA can be related in the following:

• Investigation of the root causes of problems or risks
• Identification of the causes of the root causes of the stated problems in the system
• Means and methods of correcting these problems by identifying the risk and taking steps to prevent their recurrence

Now, what are CAPA investigations?

CAPA investigations are systematic investigations an organization carries out into its Quality Systems to detect the root causes of the identified problems and risks.

CAPA investigations lie at the heart of the act of identifying the root causes of a practice. CAPA investigations are carried out to investigate the causes for which a product, process or a Quality System could be nonconforming.

All the core elements of the chain -product, process and Quality System nonconformities -apply to CAPA investigations. The FDA requires such organizations to carry out a systematic root cause investigation under the series of Secs 820 and its many sections, whose primary aim is to identify the nature and nonconformities and their extent and take corrective actions before or after they have started to get distributed into the market.

Operative part on CAPA investigations

The operative part of FDA expectation on CAPA investigations is that the CAPA investigation should be carried out in a manner that is proportionate to the degree to the extent of risk in the nonconformity.

The Preamble to FDA's CAPA guideline states that there should be proportionality between the gravity of the problem and the inherent or attendant risk and the CAPA.

Levels of CAPA investigations

CAPA investigations consist of these levels:

Read More:https://www.linkedin.com/pulse/look-capa-investigations-ronald-gardner?published=t