BEGIN:VCALENDAR VERSION:2.0 PRODID:-//ddaysoftware.com//NONSGML DDay.iCal 1.0//EN BEGIN:VEVENT DTEND:20230922T170000Z DTSTAMP:20240329T112319Z DTSTART:20220809T160000Z SEQUENCE:0 SUMMARY:Inspection Readiness Series UID:bcb7e641-9e8c-49fa-805f-e646cdc155b1 X-ALT-DESC;FMTTYPE=text/html:
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$0 per attendee or per site (Non-Member Price)<
br />\n$0 per attendee or per site (SCRS Member)
\nThis price is for
you\, or your whole site! \;
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\nNot an SCRS member? Join now to attend this webinar at the member price.
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\nContact Hours: \;1 per session\, attended Live. \;
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\nPresenter(s) - Module 1:  \ ;
\nAnthea Dransfiel d\, BSc\, MSc\, CChem\, MRSC\, Managing Director\, Advarra Consulting Lesl ie Paul\, MS\, Director\, Advarra Consulting
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Presenter - Module 2: \;
\nJan Holladay Pierre\, MPH\, CMQ/OE\, Principal (GCP)\, IQVIA Quality Compliance Solutions
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Pr esenter - Module 3
\nJan Holladay Pierre\, MPH\, CMQ/OE\, Principal (GCP)\, IQVIA Qu
ality Compliance Solutions
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< span style="font-size: 14px\; font-family: tahoma\, sans-serif\; color: bl ack\;">Presenter - Module 4: \;
\nBilly Dirkes\, VP Quality Assuranc e\, Clinical Research
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< span style="font-size: 14px\; font-family: tahoma\, sans-serif\; color: bl ack\;">Presenter - Module 5: \;
\nValaria McGee\, Senior Director\, PPD
\nDebby Brown\, Senior Director\, PPD
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\nSeries Sponsored by Advarr a \;
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\nOriginal \;Series Dates &a mp\; Times: \;
\nModule 1: Tuesday\, August 9\, 2022\, 12PM ET \;
\nModule 2: Tuesday\, August 30\, 2022\, 12PM ET
\nModule 3: T uesday\, September 6\, 2022\, 12PM ET
\nModule 4: Tuesday\, September 13\, 2022\, 12PM ET
\n< p style="margin: 0in\; line-height: normal\; font-size: 15px\; font-family : calibri\, sans-serif\;">Module 5: Thursday\, September 22\, 2022 \, 12PM ET\n \;
\nSeries Description:
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\nPresented by Advarra
\nThis 5-part webinar series will provide you with the knowledge\, tips\, tools &\; case studies that will help prepa re your site for an FDA inspection. We will start by addressing the critic al question\, &ldquo\;Why would the FDA be coming to my site?&rdquo\; Our expert line-up of speakers will not only help to put your site in the righ t mind-set\, but throughout the course and modules they will share key ele ments of what to expect from an FDA inspection at various stages and phase s.  \;Learn how and what to prepare for the visit from the time the In spector arrives at your door\, questions and requests throughout the inspe ctions\, possible outcomes\, how to implement a corrective action plan\, a nd the long term meanings for your site. We will share how to write the ac tual response inclusive of who should write it\, critical content\, as wel l as specific response examples. \;
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\nFurthe rmore\, this course will cover the role of risk based monitoring\, specifi cally that all data isn&rsquo\;t inspected equally and what sites should b e prepared for.  \;To conclude the module series\, we will also provid e an overview of how the inspection affects each stakeholder\; IRB\, Spons or and site.
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\nModule 1 : \;&ldquo\;Preparing for an Inspection&rdquo\ ; \;
\nModule 2:& nbsp\;&ldquo\;Day of Call -  \;In the Door&rdq uo\; \;
\nModule 3: \;&ldquo\;Day of Visit - The People&rdquo\;
\nModule 4: \; span>&ldquo\;Responding/Reactions/Corrective Action - Pos t Visit&rdquo\; \;
\nModule 5: \;&ldquo\;Role of RBM - How the Inspection Affects all of the Stakeholders&rdquo\; \;
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\nSpeaker Bios:
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\ nAnthea Dr
ansfield\, BSc\, MSc\, CChem\, MRSC\, Managing Director\, Advarra Cons
ulting - Quality Center of Excellence
\nWith over 25 years of experience within analytical an
d manufacturing aspects of cGMP\, operational leadership of clinical sites
\, and quality oversight spanning GxP\, \;Anthea \;brings a practi
cal approach to Quality. She advocates for structured\, phase-appropriate
procedures that are defendable and enable compliance. She has a drive for
process and attention to detail with a focus on using technology to ease t
he quality burden.
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\nLeslie Paul\, MS\, Director\, Adva rra Consulting \;
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Jan Holladay Pierre\, MPH\, CMQ/OE\, Principal (GCP)\, IQVIA Quality Compliance Soluti ons
\nOver 25 years in the R&\;D and healthcare industry with expertis e in regulatory compliance (Former FDAer) and quality assurance. SME in GC P\, GvP\, and GLP/GCLP with experience auditing against FDA requirements a nd other standards in support of pharmaceutical and medical device clinica l trials such as ICH\, ISO\, HHS/HIPAA\, EU/GDPR and CMS/CLIA. Experience in detecting inherent compliance risks with insights and perspectives work ing in government\, sponsor/Pharma\, CRO\, site\, service providers (vendo rs)\, specialty labs and hospitals. \;
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Billy Dirkes\, VP Quality Assurance\, Clinical Research
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Billy is an experienced quality assurance professional and has held multiple roles within GCP quality across all phases of human clinical res earch in both Pharma\, PPD\, and Accelerated Enrollment Solutions for over 20 years. \; Billy started his career as a study coordinator and tran sitioned into Quality Assurance holding multiple auditor positions conduct ing many audit types in multiple countries. \; He established a GCP QA function within a new Pharma company and later helped design and lead Qua lity Management System functionality within PPD in the areas of Global Pro cess Auditing\, QA Inspection Management/Consultation/Special Investigatio ns\, Global Internal Auditing\, and then transitioned into leading the AES QA functions. \; Billy has direct experience in Global GCP implementa tion\, Good Pharmacovigilance Practices\, and Computer System Validation a nd Compliance principles. \; In addition\, he has held lead roles in i nspection management for multiple regulatory authority inspections includi ng FDA\, EMA\, MHRA\, PMDA\, and Health Canada. \; Billy has a B.S. de gree in Biomedical Science from Texas A&\;M University. \; \; span>
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\nBilly believes in a collaborative approach to qua lity. \; Quality Assurance is a vital component of any quality managem ent system\, but cannot be successful without Operational partners will. span>
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Valaria McGee\, Senior Director\, PPD
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Valarie McGee is a Senior Director and leads the Systems and Innovation group within Project Delivery Process and Systems Optimization (PSO) at PPD\, a ThermoFisher company. The Systems and Innova tion team focuses on providing the knowledge and expertise to ensure that Project Delivery has industry-leading\, operationally effective systems to manage projects efficiently and expertly from start-up to completion. In addition\, the Systems and Innovation business segment provides input and influence into future systems and business transformation decisions\, in p artnership with the other PSO business segments\, to streamline and integr ate technology into Project Delivery.
\nValarie joined PPD in 2002 as a CRA in North America working in therapeutic areas such as infectious disease and gastroenterology. Since that time\, she has held the positions of Clinical Team Manager and People Manager of CRAs and People Managers. Valarie moved into the Director level within the Clinical Operations depar tment in 2018 and transitioned to Project Delivery in 2021. Prior to joini ng PPD\, she worked in medical device endocrinology and oncology research and development as a Research Biochemist. During graduate school\, Valarie worked in the field of forensic science in crime scene investigation and forensic detection and taught undergraduate organic chemistry. \;  \;
\nValarie holds a master&rsquo\;s degree in Biochemistry from th e University of Alabama. She is a member of the Association of Clinical Re search Professionals and was a silver medal winner at the Pharmatimes Clin ical Researcher of the year team competition in 2015. She has a teenage so n\, two cats and\, in her free time\, she enjoys golfing and reading a gre at mystery. Valarie is an enthusiastic supporter of the arts and is the Vi ce Chairman of the board for the Chattanooga Boys Choir. \;
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\nDebby Brown\, Senior Director\, PPD
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Debby Brown has more t han 25 years of industry experience including CRO and BioPharma positions. Her current role is Senior Director for PPD with focus on RBQM. In this r ole\, she serves as an internal consultant and provides support to staff a round ICHE6R2 adherence. Prior to this\, she served in many roles in opera tions. Debby began as a CRA and has had responsibilities including leading a business unit. She has worked for both Biotech and CRO providers during my career. Debby loves the challenges that come with drug development and loves to see treatments which are possible because research and developme nt is possible.
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Society fo r Clinical Research Sites\, Inc. is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center&rsquo\;s Co mmission on Accreditation.
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To obtain your Contact Hours for this webinar: \;
\nPlanners\, presenters\, faculty\, authors\, and content reviewers do not have any relevant financ ial relationships with any commercial interest.
\nThis webinar doe s not imply any endorsement of products or services by the Society for Cli nical Research Sites or ANCC.
\nThe materials and recording of thi s webinar will be available for one year as an archive\, but will not awar d any contact hours.
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