BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T083628Z UID:9f8691c3-662b-48cb-abb1-2a9f33b9b988 DTSTART:20201123T083000 DTEND:20201124T083000 CLASS:PRIVATE DESCRIPTION:
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FREE $100 AMAZON GIFT CARD! ***
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\n\nFDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency&rsquo\;s e valuation of the compliance status of regulated companies representing mul tiple industries - pharmaceuticals\, biologics\, medical devices\, as well as foods and cosmetics - as well as the contract QC laboratories which se rvice these industries. Lack of compliance can result in severe regulatory actions\, criminal liability\, fines\, and the inability to obtain produc t approvals.
\n\nThis course will examine the fundamental requiremen ts for all QC laboratories subject to FDA inspection\, recent trends from FDA inspection reports and enforcement actions. In addition\, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay &ldquo\;current&rdquo\; with FDA requirements (cGMPs and GLPs).
\n\n \;
\n\nSeminar Fee Includes:
\n
\nLunch
\nAM-PM Tea/Coffee
\nSeminar Material
\nUSB with seminar presentation
\nHard copy of presentation
\nA
ttendance Certificate
\n$100 Gift Cert for next seminar
\n
\nLearning Objectives:
Key goals of the confere nce will include learning:
\n\nThe basics of FDA law a nd regulations governing QC laboratories responsible for testing research materials\, components of FDA-regulated products\, and finished FDA-regula ted products (pharmaceuticals\, biologics\, medical devices\, cosmetics\, and foods).
\nLaboratory organization\, personnel qu alification and training requirements.
\nDocumentati on and record-keeping requirements\, including e-records and data integrit y.
\nSample integrity requirements.
\nManagement and control of stability (shelf-life) studies.
\n li>\nAnalytical methods verification and validation.
\nManagement and control of laboratory instruments.
\nManagement and control of laboratory supplies.
\nProper conduct of laboratory investigations.
\nConsequences of laboratory non-compliance.
\n \;
\n\nWho will Benefit:
\n\n
\nSen
ior directors\, managers\, supervisors and those who have responsibility f
or ensuring that QC laboratory operations and practices comply with curren
t good manufacturing practices and good laboratory practices.
Quality Assurance
\nQuality Control
\ nResearch &\; Development
\n< br />\nAGENDA
\n\n
\nDay 01(8:30 AM -
4:30 PM)
\n08.30 AM - 09.00 AM: Registration
\n09.00 AM: Session Start
\nBasics of FDA law and regulations for QC
laboratories
\nWhat is adulteration?
\nPharmaceuticals
\nB
iologics
\nMedical Devices
\nFoods
\nCosmetics
\nWhat
is CGMP?
\nPharmaceuticals
\nBiologics
\nMedical Devices
\nFoods
\nCosmetics
\nWhat is GLP?
\nWhat is AIP?
\
nContract Laboratories
\nFDA inspection methodology
\nLaboratory
Organization
\nOrganization
\nPersonnel qualification and train
ing
\nDocumentation and record-keeping requirements
\nStandard O
perating Procedures
\nAnalytical Methods
\nRaw data (notebooks\,
print-outs)
\nDocument management (change control\, retention)
\nPart 11 (electronic records and signatures)
\nSample integrity requ
irements
\nSample collection
\nSample delivery\, handling\, disp
osition
\nRetain samples
\nStability (shelf-life) studies
\
nOrganization and management
\nStorage units
\nAnalytical method
ology
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\n\nDay 02(8:30 AM - 1:00 PM)
\n \;
Analytical methods verification and validation
\nProtocols
\nTests
\nDocumentation
\nManagement and
control of laboratory instruments
\nQualification
\nCalibration<
br />\nMaintenance
\nManagement and control of laboratory supplies
\nStandards
\nReagents\, chemicals
\nProper conduct of labora
tory investigations
\nOut-of-specification results
\nOut-of-norm
results
\nRoot cause analysis
\nDocumentation
\nConsequenc
es of laboratory non-compliance
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\n\nSPEAKE R
\n\n\n\n
Robert C Fish
\nConsultant\
, EAS Consulting Group\, LLC
Mr. Fish has been providin g independent consulting services since 2003\, joining EAS Consulting Grou p\, LLC in November 2006. Prior to that he started work for AAC Consulting Group\, Inc. (AAC) in April 1995 after serving 33 years with Food and Dru g Administration (FDA). The last 6 years of that service he held the posit ion of Director\, Division of Field Investigations (DFI). He was responsib le for general policy and guidance for the Agency&rsquo\;s domestic and in ternational investigation activities. He also managed the foreign inspecti ons'\; operations. Prior to that position\, Mr. Fish was Director of Co mpliance at the Nashville District Office for 8 years and was also a Super visory Investigator at the Nashville District Office for 8 years. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962\, and subsequently served as an Investigator at the Grand Rapids Res idence Post and the Detroit District Office. Mr. Fish is experienced in al l aspects of FDA regulated products. He has expertise in compliance matter s and Current Good Manufacturing Practice Regulations (GMPs) as they relat e to pharmaceutical\, dietary supplements\, tobacco\, device\, and biologi cs manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and i s an AFDO Certified HACCP Instructor.
\n\n \;
\n\nPlease c
ontact the event manager Marilyn (marilyn.b.turner@nyeventslist.com ) belo
w for:
\n- Multiple participant discounts
\n- Price quotations o
r visa invitation letters
\n- Payment by alternate channels (PayPal\,
check\, Western Union\, wire transfers etc)
\n- Event sponsorships\n
\nNO REFUNDS ALLOWED ON REGISTRATIONS
\nService fees incl
uded in this listing.
\n---------------------------------------------
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