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

Why is FDA at my Facility, and what do I do During an Inspection

Successful completion of Singapore Seminar by NetZealous on the topic “Why is FDA at my Facility, and what do I do During an Inspection” by David R. Dills

Fremont, CA, Jul , 19 2016: A highly interactive two-day seminar on the topic, “Why is FDA at my Facility, and what do I do During an Inspection”, was organized in Singapore by NetZealous, a leading Provider of Regulatory Compliance Trainings for a wide range of regulated industries on July 18th & 19th, 2016. The Speaker at this seminar was David Dills, Regulatory Affairs & Compliance Consultant.

This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.

This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome.

This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

More details about the seminar can be had from http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900547

About the Director:

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space.

He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

About NetZealous:

NetZealous, a Fremont, CA-registered organization, DBA  GlobalCompliancePanel offers a broad range of high quality regulatory and compliance-related professional trainings and services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biological, drugs, food and biotechnology.

CEO of NetZealous, Satisha Naraharimurthy, has expressed his happiness and satisfaction that this seminar was held at a time when laboratories are seen to be struggling with their core issues relating to equipment qualification, calibration and computer system validation processes. He is satisfied that his organization served an important learning need for such professionals.

An understanding of what laboratory professionals need to do in order to meet regulatory requirements was what this seminar intended to impart, and it has done its job rather well, felt Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at NetZealous.

The learning gained at this two-day seminar, which was packed with both substance and articulation, will go a long way in helping laboratory personnel at various levels understand ways by which to sort out the issues they have in relation to equipment qualification, calibration and computer system validation processes, believes Liju Mathew, Co-Founder and Chief Business Development Officer at NetZealous.

Contact information:

Call: 1-800-447-9407;

Visit: http://www.netzealous.com/