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.

1. Successful completion of Singapore Seminar by NetZealous on the topic Why is FDA at y Fa ility, a d hat do I do Duri g
a I spe tio y Da id R. Dills
Fremont, CA, Jul , 19 2016: A highly interactive two-day se i ar o the topic, Why is FDA at my Facility, and what do I do
During an Inspection , was orga ized i 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:

2. 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/