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/
Labels: During an Inspection, FDA inspection, Singapore Seminar by NetZealous, various types of inspections