B-2 85 minutes
Tactical Questioning
Laurie Taddonio, LMT Consulting LLC
Robin Guy, Robin Guy Consulting, LLC
William Vincent, G-Frog Consulting
While the FDA, FBI, and other law enforcement are provided training in investigative interviewing, our industry QA professionals rarely have such training to assist them in conducting their roles including, but not limited to, performing audits and... Details
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Session AA - 60 minutes
AA-1: Data Integrity - A Document Control Challenge - Kevin Bogert, Azimuth Compliance Consulting, LLC
AA-2: Challenges and Best Practices for Modernizing CSV - Dori Gonzalez-Acevedo, Tx3 Services, LLC
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Session B - 83 minutes
B-1: Remoting Auditing -- the Good, the Unusual, and the Unexpected! - Joseph Whittemore, Keowee Quality Consulting; Matt Hansen, Covance; Richard Siconolfi, Richard M Siconolfi, LLC; Vince D'Angelo, Instem; Rene Kasan, 37 Centigrades AG; Santosh Tharkude, Johnson & Johnson
B-2: REMOTE GCP AUDITS - HOW TO AUDIT IN THE TIME OF COVID - Michael Hamrell, MORIAH Consultants
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Session BB - 60 minutes
BB-1: Quality Oversight in the Post-Marketing Environment: Considerations for Pharmacovigilance Audits and Ongoing Inspection Readiness - Larry Thomas, Bayer Pharmaceuticals; Karen Ward, Alexion Pharmaceuticals, Inc.
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Session C - 73 minutes
C-1: Strategies for Ensuring Part 11/Annex 11 Compliance for Research Sites - James Riddle, Advarra
C-2: The Renovation of ICH E8: General Principles for Clinical Studies - Mark Levenson, US FDA
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Session CC - 90 minutes
CC-1: Piecing together the Past: Turning a Phase 1 study into an NDA inspection-ready study after the fact. Lessons learned when the impossible became reality - Jeanine Pitts, Pitts Quality Consulting
CC-2: Shifting Our Industry from Inspection Readiness to Inspection Ready? Yes!: Challenges, Strategies, & Solutions - Penelope Przekop, PDC Pharma Strategy
CC-3: Please Don't Paint the Doorknobs: ... Details
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Session D - 69 minutes
D-1: Navigating Constant Change With Flexible Quality Systems - Kim Jackson, Master Control; Erin Wright, Master Control
D-2: Unifying Quality Management for a New Era of Medicine - Snehal Srikrishna, Veeva Systems
presentation D-3 was not permitted to be included in these recordings
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Session EE - 27 minutes
presentation EE-1 was not permitted to be included in these recordings
EE-2: The Art and Science of the Debriefing Meeting - Richard Siconolfi, Richard M. Siconolfi, LLC
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Session F - 34 minutes
F-1: A Risk-Based Approach to the Implementation and Validation of an Electronic Informed Consent (eIC) framework for REDCap - Joseph Franchetti, JAF Consulting, Inc.; Gaurav Kumar, JAF Consulting, Inc.
presentation F-2 was not permitted to be included in these recordings
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Session FF - 66 minutes
FF-1: Considerations for Converting Hardcopy Data to Electronic Image Files for GLP/GCP Purposes - Dan Carey, Quality Associates, Inc
presentation FF-2 was not permitted to be included in these recordings
FF-3: Basic IT and QA Requirements for Digital Pathology GLP Compliance - Elizabeth Neyens, FlandersToxPathConsulting
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Session G - 55 minutes
G-1: A Sponsor, A Site and an Auditor: A perspective on quality at Clinical Sites - Cheryl McCarthy, Ironwood Pharmaceuticals; Celeste Gonzalez, Boston Scientific; Jill Heinz, Family Care Research
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Session H - 25 minutes
H-1: Impact of the New EU MDR Regulation on the Implementation of Design Controls - Tsvia Erlich, N.G.I.T. Premium Consulting
presentation H-2 was not permitted to be included in these recordings
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Session HH - 44 minutes
HH-1: Auditing across the GCP, GLP and cGMP Regulations - Barbara Munch, Munch GLP Consulting; Greg Furrow, Mustang Bio, Inc; Thomas Purdue, Boehringer Ingelheim.Pharmaceuticals, Inc.; David Glasgow, US Food and Drug Administration; Cheryl McCarthy, Ironwood Pharmaceuticals; Deborah Eyer Garvin, Pacific Rim GLP Training and Consulting
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Session I - 70 minutes
I-1: Enhance Patient Compliance Via Electronic Patient Reported Outcomes - Ann-Marie Kiser, Prelude Dynamics LLC
I-2: One CVM Approach to Quality - Part 1 - Matthew Lucia, US FDA; Timothy Schell, US FDA; Regina Tan, US FDA
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Session II - 50 minutes
II-1: Medical Device Cybersecurity - Kevin Fu, US FDA
II-2: Software as a Medical Device (SaMD) and Updates from the Associated 2019 Pilot Program - Bakul Patel, US FDA
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Session J - 82 minutes
J-1: Soft Skills That Create Quality Leaders Highlighted in the COVID Pandemic Response - Kimberly Wanick, Advanced Clinical
J-2: Quality Culture Implementation with Executive Management - Melanie Willis, Ethicon Endo-Surgery
J-3: Hindsight is 20/20: Developing and Fostering Effective Pharma-CRO Partnerships During Times of Turbulence - Stacy Newalu, Advanced Clinical
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Session JJ - 60 minutes
JJ-1: Risky Business: Assessment for Appropriate Inspection Intervals - Megan Lawhead, Charles River Laboratories; Deanna Talerico, Charles River Laboratories; Lindsay Nolan, Charles River Laboratories; Megan Callan, Abeona Therapeutics; Joshua Hittle, Charles River Laboratories
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Session K - 90 minutes
K-1: GLP Regulations – Refocus on the Basics - Barbara Munch, Munch GLP Consulting; Lori Wright, Southern Research; Gina Tucker, Zigzag Associates Ltd
K-2: Comparison between EPA and FDA GLPs - Barbara Munch, Munch GLP Consulting; Johanna Mazlo, IR-4 Project
K-3: The Art of Conducting Successful GLP Audits: For the Early Career Professional - Sesha Jackson-Woodard, Johnson and Johnson
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Session L - 80 minutes
L-1: What Do We Do Now With Computer Software Assurance (CSA)? - Stacey Blackmer, GlaxoSmithKline; Randall Basinger, Common Sense Validation Consultants, LLC
L-2: Making a case for a quality program manager that is related to the CSA guidance - Francisco Vicenty, US FDA
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Session M - 65 minutes
M-1: One CVM Approach to Quality - Part 2 - Cynthia Smith, US FDA; Vernon Toelle, US FDA; Jordan Desilva, US FDA
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Session N - 30 minutes
presentation N-1 was not permitted to be included in these recordings
N-2: Trends in Inspections, Case Study Examples, Post Inspectional Correspondence, and Key Messages - Miah Jung, US FDA
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Session O - 34 minutes
O-1: Root Cause Analysis: Cause and Effect Evaluations - JoAnn Boyd, Southwest Research Institute
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Session P - 60 minutes
P-1: THINK! Implementation of CSA Requires Critical Thinking for Data Integrity - Stacey Blackmer, GlaxoSmithKline
P-2: Information Security & its Relationship with Computer Validation, Information Technology & Compliance - Phil Geens, Instem
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Session R - 57 minutes
presentation R-1 was not permitted to be included in these recordings
R-2: Notes to File - when are they appropriate? - Dawn Niccum, inSeption Group
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Session S - 97 minutes
S-1: Maintaining a Balance between GLP Compliance and Sponsor Expectactions: A CRO Perspective - Josee Ann Dulude, Charles River Laboratories; Stephanie Rene, Charles River Laboratories
S-2: Steering through Regulatory Biomarker Qualification Expectations - Christopher Tudan, Gilead Sciences
S-3: Challenges Facing GLP Analytical Laboratories Performing Preclinical and Clinical Sample Analysis - Sara... Details
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