Loading…
GCP Inspection Readiness has ended

Log in to bookmark your favorites and sync them to your phone or calendar.

Monday, December 5
 

8:00am EST

Registration and Continental Breakfast for Workshop Participants
Monday December 5, 2022 8:00am - 8:30am EST
  Networking

8:30am EST

AM WORKSHOP: INSPECTION READINESS PLAN
Outline the Critical Components of an Effective Inspection Readiness Plan
  • Define the purpose of an inspection readiness plan
  • Discuss who should be responsible for developing and managing the plan
  • Assess inspection risks and identify critical areas of focus
  • Develop an inspection readiness plan that effectively addresses identified risk areas  
  • Identify best practices for execution of the plan and assessing effectiveness
Speakers
avatar for Elizabeth Bodi

Elizabeth Bodi

Principal Consultant, Organization and Quality Solutions, HALLORAN CONSULTING GROUP
Elizabeth Bodi has over 30 years of experience in the biopharmaceutical and medical device industry and is currently a Principal Consultant with Halloran Consulting Group. Her career focused primarily on clinical operations, training and clinical quality assurance activities to ensure... Read More →
avatar for Susan Greenbowe

Susan Greenbowe

Executive Director, Clinical QA, CHINOOK THERAPEUTICS
Susan Greenbowe has over 20 years of experience in the biopharmaceutical industry and is currently the Executive Director, Clinical Quality Assurance at Chinook Therapeutics. Her career has focused primarily on clinical quality assurance activities establishing fit-for-purpose GxP... Read More →

Monday December 5, 2022 8:30am - 12:00pm EST
  In-Person Experience ONLY

12:00pm EST

Lunch for Workshop Participants
Monday December 5, 2022 12:00pm - 1:00pm EST
  Networking

1:00pm EST

PM WORKSHOP: MOCK INSPECTIONS
Leverage Mock Inspections to Ensure a Constant State of Inspection Readiness
  • Understand the purpose of a mock inspection and mock interviews and effectively articulating this to your team
  • Strategize and plan your own mock inspection
  • Leverage the mock interview to train staff on best practices and what not to do
  • Implement follow-up activities for areas that need improvement
Speakers
avatar for Jennifer Stamper

Jennifer Stamper

Director, TMF Services and Business Operations, JUST IN TIME GCP
25+ years in management and development of staff to support client portfolios with projects in all phases,systems and models.  Clinical research expertise with a focus on the health and completeness of the TrialMaster File through inspection readiness activities.
avatar for Donna Dorozinsky

Donna Dorozinsky

President and CEO, JUST IN TIME GCP

Monday December 5, 2022 1:00pm - 4:30pm EST
  In-Person Experience ONLY

4:30pm EST

Workshop Day Concludes
Monday December 5, 2022 4:30pm - 4:30pm EST
 
Tuesday, December 6
 

8:00am EST

Registration and Continental Breakfast
Tuesday December 6, 2022 8:00am - 8:30am EST
  Networking

8:30am EST

CHAIRPERSON'S WELCOME AND INDUSTRY UPDATE
Speakers
avatar for Dawn Niccum

Dawn Niccum

Executive Director, QA and Compliance, INSEPTION GROUP
With over 25 years of Clinical Operations and Quality Assurance pharmaceutical experience, Dawn provides clients a unique perspective of efficiency, speed, and compliance. She is an experienced leader in clinical compliance, SOP development, computer system validation, quality document... Read More →

Tuesday December 6, 2022 8:30am - 9:00am EST
  Included in Virtual Experience

8:30am EST

REGULATORY ENVIRONMENT
Examine the Elements of ICH E6 R2/R3 and ICH E8 that Should Be Driving Your GCP Inspection Readiness Approach 
  • Understand the elements of E8 that relate to inspection and inspection readiness
  • Identify the principles of ICH E6(R2) that impact inspection readiness procedures
  • Discuss what was added to ICH E6(R3) and the reason for the revision
Speakers
avatar for Donna Dorozinsky

Donna Dorozinsky

President and CEO, JUST IN TIME GCP

Tuesday December 6, 2022 8:30am - 9:00am EST
  Included in Virtual Experience

9:30am EST

SENIOR LEADERS PANEL: QUALITY CULTURE AND INSPECTION READINESS
Discuss How the Health of Your Organization’s Quality Culture Impacts Your Ability to Achieve Inspection Readiness 
  • Understand the connection between culture of quality and inspection readiness
  • Identify ways to diagnose the health of your culture of quality
  • Share easy things that can be done to improve your culture of quality 
  • Recognize the importance of having a quality strategy and examples of how that impacts inspection readiness
Speakers
avatar for Dawn Lundin

Dawn Lundin

Head of Global Quality, MAPS PBC
Recognized expert in GxP risk based quality management and compliance from 25 years in drug/vaccine development, quality oversight, and compliance roles. Current Head of Global Quality Management Systems for MAPS Public Benefit Corporation and faculty member of the Institute for Translational... Read More →
avatar for Michael Torok, Ph.D.

Michael Torok, Ph.D.

Global Head, Quality Assurance Programs, F. HOFFMAN-LA ROCHE and GENENTECH
avatar for Michael Wieczerzak, MS, MBA, MPH, CCRP

Michael Wieczerzak, MS, MBA, MPH, CCRP

Associate Director, Clinical Quality Management Lead, EMD SERONO
Michael Wieczerzak is an Associate Director, Clinical Quality Management Lead at EMD Serono. His main responsibilities are within inspection readiness, quality risk management and trial oversight. Prior to joining the Clinical Quality Management department, he was a Clinical Trial... Read More →
avatar for Tim Stoddard

Tim Stoddard

Quality Consultant/Advisor; Previous Head of Quality, FLATIRON HEALTH; Previous Clinical Quality Leader, SPARK THERAPEUTICS
Tim Stoddard has 19 years of broad quality experience in research (clinical, non-clinical, pharmacovigilance, real-world evidence), therapy development (drugs, biologics, cell & gene therapies, combination products, medical devices), technology (software development, computer systems... Read More →

Tuesday December 6, 2022 9:30am - 10:30am EST
  Included in Virtual Experience

10:30am EST

Networking and Refreshment Break
Tuesday December 6, 2022 10:30am - 11:00am EST
  Networking

11:00am EST

FDA KEYNOTE: GCP INSPECTION UPDATE
Examine Recent BIMO Updates as well as GCP Inspection Trends, Metrics and Regulatory Actions 
  • Discuss the recent updates to BIMO and what this means for inspections
  • Outline recent inspection findings and metrics
  • Understand the FDA’s focus Risk-Based Quality Management and how this translates into inspections
Speakers
avatar for Chrissy J. Cochran, Ph.D.

Chrissy J. Cochran, Ph.D.

Director, Office of Bioresearch Monitoring Operations, ORA, FDA

Tuesday December 6, 2022 11:00am - 12:00pm EST
  Included in Virtual Experience

12:00pm EST

DIFFERENT REGULATORY AGENCY INSPECTIONS
Compare and Contrast the Main Differences Between GCP Inspections by Varying Global Regulatory Agencies to Ensure Effective Preparation 
  • Understand how different agencies tend to behave during inspections and how that can impact your preparation
  • Evaluate which areas you can anticipate the inspector focusing on, based on which agency they represent
  • Discuss expectations and onsite requirements during the inspection from different agencie

Speakers
avatar for Crissy MacDonald, Ph.D.

Crissy MacDonald, Ph.D.

Vice President, Client Delivery, WCG AVOCA
As the leader of WCG Avoca’s integrated consulting and research solutions Cristin MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has over 12... Read More →

Tuesday December 6, 2022 12:00pm - 12:30pm EST
  Included in Virtual Experience

12:30pm EST

FOR VIRTUAL ATTENDEES ONLY
Interactive Discussions on Inspection Readiness Best Practices - Guided Conversations Prompted by Videos 
  • Engage with fellow virtual participants to problem solve and collaborate on topics to optimize inspection readiness
  • Discuss the main themes of the conference and how to apply at your company
  • Share challenges and successes with like-minded peers and leave with new relevant connections
Tuesday December 6, 2022 12:30pm - 1:30pm EST
  Included in Virtual Experience

12:30pm EST

Lunch
Tuesday December 6, 2022 12:30pm - 1:30pm EST
  Networking

1:30pm EST

PANEL DISCUSSION: INSPECTION PREPARED
Being Inspection Ready Doesn’t Mean Inspection Prepared
  • Understand the “Story of the Study” through effective oversight
  • Recognize that the study documentation must support the study story
  • Assess if the “Story of the Study” and the TMF are aligned
  • Identify gaps in study documentation and inconsistencies with the study story to ensure inspection preparedness
Speakers
avatar for Susan Johansson

Susan Johansson

Senior Director, Clinical Operations, MATINAS BIOPHARMA
Susan Johansson, MS, CCRA has over 20 years of combined experience in project management and clinical research operations serving various roles from Clinical Research Associate to her current position as Senior Director of Clinical Operations. She has worked at several small to mid-size... Read More →
avatar for Lynn O'Connell

Lynn O'Connell

Global Clinical Operations, Director of Clinical Quality Management, DAIICHI SANKYO INC.
My passion is helping clinical operational functions achieve  a steady state of inspection readiness throughout the entire lifecycle of the trial.  I have over 20 years of experience in the pharmaceutical industry across multiple settings and multiple roles/functions.  I have worked... Read More →
avatar for Donna Dorozinsky

Donna Dorozinsky

President and CEO, JUST IN TIME GCP

Tuesday December 6, 2022 1:30pm - 2:30pm EST
  In-Person Experience ONLY

2:30pm EST

INTERACTIVE CROWD-SOURCING: INSPECTION INTELLIGENCE
Optimize Inspection Intelligence to Drive an Effective GCP Inspection Readiness Approach   
  • Recognize lessons from inspections as insight that should be influencing your inspection readiness approach
  • Discuss varying sources of information to understand current areas of inspection focus
  • Support your culture of quality by obtaining and sharing insight on inspections and their outcomes
Speakers
avatar for Dawn Niccum

Dawn Niccum

Executive Director, QA and Compliance, INSEPTION GROUP
With over 25 years of Clinical Operations and Quality Assurance pharmaceutical experience, Dawn provides clients a unique perspective of efficiency, speed, and compliance. She is an experienced leader in clinical compliance, SOP development, computer system validation, quality document... Read More →
avatar for Sheila Gwizdak

Sheila Gwizdak

Vice President, Quality, HALLORAN CONSULTING GROUP
Sheila Gwizdak has over 25 years of experience in the biotechnology and pharmaceutical industry. Her career has focused on people, process, data and technology optimization and innovation. She has led the execution of large scale corporate and department-level initiatives supporting... Read More →

Tuesday December 6, 2022 2:30pm - 3:00pm EST
  In-Person Experience ONLY

3:00pm EST

Networking and Refreshment Break
Tuesday December 6, 2022 3:00pm - 3:30pm EST
  Networking

3:30pm EST

ROUNDTABLE DISCUSSIONS
Each conference participant selects one topic from the following list to discuss in an intimate setting.  You’ll be asked for your topic selections via email a few weeks out from the conference and will have the opportunity to also sign up onsite.
  1. SYSTEM ACCESS:  Discuss Which Regulatory Agencies Want Access to Your Clinical Systems and Associated Challenges 
  2. ASSESS INSPECTION RISK: Understand how to Evaluate the Study and Determine the Level of Risk Related to GCP Inspections  
  3. RISK-BASED INSPECTION READINESS: Shift to A Proactive Inspection Readiness Approach and Avoid the Stress and Challenges of Last-Minute Preparation
  4. LESSONS LEARNED COMMUNICATION: Assess Effective Approaches for Speaking with Non-Quality Leadership Following an Inspection About Lessons Learned
  5. SMALL COMPANY PERSPECTIVE: Share Best Practices Building In Quality at Small Companies
  6. ROLES AND RESPONSIBILITIES:  Outline the Main Roles Needed During the Inspection and Who is Best Suited to Assign and Execute
  7. THE INSPECTION:  Walk Through the Steps of the Actual Inspection, both Front and Back Rooms, to Understand How to Best Prepare 

Speakers
avatar for Tim Stoddard

Tim Stoddard

Quality Consultant/Advisor; Previous Head of Quality, FLATIRON HEALTH; Previous Clinical Quality Leader, SPARK THERAPEUTICS
Tim Stoddard has 19 years of broad quality experience in research (clinical, non-clinical, pharmacovigilance, real-world evidence), therapy development (drugs, biologics, cell & gene therapies, combination products, medical devices), technology (software development, computer systems... Read More →
avatar for Caro Unger

Caro Unger

Director, Clinical Operations, KINNATE BIOPHARMA INC.
Oncology clinical operations professional with over 15 years of experience providing oversight on all phases of studies: global phase III confirmatory to phase 1 heathy volunteer. Have worked in melanoma, prostate, ovarian, solid tumor, AML, myelofibrosis, CLL/SLL, pancreatic, CRC... Read More →

Tuesday December 6, 2022 3:30pm - 4:15pm EST
  In-Person Experience ONLY

4:15pm EST

Networking Reception
Tuesday December 6, 2022 4:15pm - 5:30pm EST
  Networking
 
Wednesday, December 7
 

8:30am EST

Registration and Continental Breakfast
Wednesday December 7, 2022 8:30am - 9:00am EST
  Networking

9:00am EST

CHAIR WELCOME
Speakers
avatar for Dawn Niccum

Dawn Niccum

Executive Director, QA and Compliance, INSEPTION GROUP
With over 25 years of Clinical Operations and Quality Assurance pharmaceutical experience, Dawn provides clients a unique perspective of efficiency, speed, and compliance. She is an experienced leader in clinical compliance, SOP development, computer system validation, quality document... Read More →

Wednesday December 7, 2022 9:00am - 9:15am EST
  In-Person Experience ONLY

9:15am EST

THE INSPECTION CHECKLIST
Develop a Checklist Based off Regulatory Documentation to Ensure Inspection Readiness 
  • Utilize the Bioreserach Monitoring (BIMO) Compliance Manual, EMA Guidelines and other documents to create a checklist
  • Outline the critical components of this list and what questions may arise as a result
  • Leverage the checklist as a proactive tool to generate questions for a mock FDA inspection
Speakers
avatar for Loreena Sadowski

Loreena Sadowski

Senior Director RDQ-Clinical Inspection Management, BRISTOL MYERS SQUIBB
I lead a global Inspection Management team that prepares and manages GCP inspections across all therapeutic areas and regulatory agencies.  My team also works with process owners and operational leaders to optimize processes that support successful inspections, ensuring our medicines... Read More →

Wednesday December 7, 2022 9:15am - 9:45am EST
  In-Person Experience ONLY

9:45am EST

ROUNDTABLE DISCUSSIONS
Each conference participant selects one topic from the following list to discuss in an intimate setting.  You’ll be asked for your topic selections via email a few weeks out from the conference and will have the opportunity to also sign up onsite.
  1. SYSTEM ACCESS:  Discuss Which Regulatory Agencies Want Access to Your Clinical Systems and Associated Challenges 
  2. ASSESS INSPECTION RISK: Understand how to Evaluate the Study and Determine the Level of Risk Related to GCP Inspections  
  3. RISK-BASED INSPECTION READINESS: Shift to A Proactive Inspection Readiness Approach and Avoid the Stress and Challenges of Last-Minute Preparation
  4. LESSONS LEARNED COMMUNICATION: Assess Effective Approaches for Speaking with Non-Quality Leadership Following an Inspection About Lessons Learned
  5. SMALL COMPANY PERSPECTIVE: Share Best Practices Building In Quality at Small Companies
  6. ROLES AND RESPONSIBILITIES:  Outline the Main Roles Needed During the Inspection and Who is Best Suited to Assign and Execute
  7. THE INSPECTION:  Walk Through the Steps of the Actual Inspection, both Front and Back Rooms, to Understand How to Best Prepare 

Speakers
avatar for Tim Stoddard

Tim Stoddard

Quality Consultant/Advisor; Previous Head of Quality, FLATIRON HEALTH; Previous Clinical Quality Leader, SPARK THERAPEUTICS
Tim Stoddard has 19 years of broad quality experience in research (clinical, non-clinical, pharmacovigilance, real-world evidence), therapy development (drugs, biologics, cell & gene therapies, combination products, medical devices), technology (software development, computer systems... Read More →
avatar for Caro Unger

Caro Unger

Director, Clinical Operations, KINNATE BIOPHARMA INC.
Oncology clinical operations professional with over 15 years of experience providing oversight on all phases of studies: global phase III confirmatory to phase 1 heathy volunteer. Have worked in melanoma, prostate, ovarian, solid tumor, AML, myelofibrosis, CLL/SLL, pancreatic, CRC... Read More →

Wednesday December 7, 2022 9:45am - 10:30am EST
  In-Person Experience ONLY

10:30am EST

Networking and Refreshment Break
Wednesday December 7, 2022 10:30am - 11:00am EST
  Networking

11:00am EST

THE ROLE OF TRAINING
Demonstrate How Training Can be Effectively Used as an Inspection Readiness Tool and How to Appropriately Document
  • Understand what kind of cross-functional training can prioritize quality and drive ongoing inspection readiness
  • Evaluate when this training should take place to ensure inspection readiness
  • Discuss how training is documented and where that documentation should live 
Speakers
avatar for Michele Weitz

Michele Weitz

Executive Director, Clinical Standards and Innovation, CLOVIS ONCOLOGY

Wednesday December 7, 2022 11:00am - 11:30am EST
  In-Person Experience ONLY

11:30am EST

FIRESIDE CHAT: GCP AUDITS
Leverage Internal and External Audits to Gain Confidence in GCP Inspection Preparedness
  • Analyze how an effective audit strategy measures and drives the inspection readiness of clinical vendors and sites
  • Evaluate the use of internal audits and how to best execute
  • Discuss partnerships between quality, compliance, and auditing teams to work together to ensure inspection readiness
Speakers
avatar for Tim Stoddard

Tim Stoddard

Quality Consultant/Advisor; Previous Head of Quality, FLATIRON HEALTH; Previous Clinical Quality Leader, SPARK THERAPEUTICS
Tim Stoddard has 19 years of broad quality experience in research (clinical, non-clinical, pharmacovigilance, real-world evidence), therapy development (drugs, biologics, cell & gene therapies, combination products, medical devices), technology (software development, computer systems... Read More →
avatar for Karin Rezzonico

Karin Rezzonico

Senior Director, Quality Assurance Auditing, INSEPTION GROUP
Experienced Clinical Quality AD and Communications and Change Management practitioner with a demonstrated history of working in the pharmaceutical and biotechnology industries. Study management experience in all phases of clinical trials for Oncology, Virology and Metabolic Therapeutic... Read More →

Wednesday December 7, 2022 11:30am - 12:15pm EST
  In-Person Experience ONLY

12:15pm EST

Lunch
Wednesday December 7, 2022 12:15pm - 1:15pm EST
  Networking

1:15pm EST

PROACTIVE QUALITY BRIEF
Maximize Transparency with Health Authorities through Submission of Proactive Quality Briefs to Streamline Approvals and Facilitate Inspections
  • Discuss the purpose of a Quality Brief and what it hopes to accomplish, including a clear Quality Position Statement
  • Execute a risk assessment across defined impact factors and showcase how any identified issues are being mitigated
  • Evaluate the potential benefits, specifically enabling industry and regulatory authorities to focus on impact and outcomes, getting new products to patients faster
  • Share short-term and long-term goals for implementation and how to get there  
Speakers
avatar for Paula Walker

Paula Walker

Quality Policy Chapter Lead, ROCHE; Former Head of Compliance, MHRA
A new chapter started in Sept 2022 moving to Roche-Genentech as Quality Policy Chapter Lead on the PDQ Global leadership team with the aim of using quality as an enabler, getting new medicines to patients faster. Previously Head of Compliance (1) at the MHRA, responsible for the GCP... Read More →

Wednesday December 7, 2022 1:15pm - 2:00pm EST
  Included in Virtual Experience

2:00pm EST

EXPERT PANEL: GCP INSPECTION BUZZ
Learn from Recent GCP Inspection Experiences and Communication with Varying Regulatory Authorities 
  • Learn the latest inspection gossip and what this might mean for your inspection readiness practices
  • Evaluate challenges with recent inspections due to COVID
  • Discuss experiences with hybrid and remote inspections
Speakers
avatar for Dawn Niccum

Dawn Niccum

Executive Director, QA and Compliance, INSEPTION GROUP
With over 25 years of Clinical Operations and Quality Assurance pharmaceutical experience, Dawn provides clients a unique perspective of efficiency, speed, and compliance. She is an experienced leader in clinical compliance, SOP development, computer system validation, quality document... Read More →
avatar for Paula Walker

Paula Walker

Quality Policy Chapter Lead, ROCHE; Former Head of Compliance, MHRA
A new chapter started in Sept 2022 moving to Roche-Genentech as Quality Policy Chapter Lead on the PDQ Global leadership team with the aim of using quality as an enabler, getting new medicines to patients faster. Previously Head of Compliance (1) at the MHRA, responsible for the GCP... Read More →
avatar for Loreena Sadowski

Loreena Sadowski

Senior Director RDQ-Clinical Inspection Management, BRISTOL MYERS SQUIBB
I lead a global Inspection Management team that prepares and manages GCP inspections across all therapeutic areas and regulatory agencies.  My team also works with process owners and operational leaders to optimize processes that support successful inspections, ensuring our medicines... Read More →

Wednesday December 7, 2022 2:00pm - 3:00pm EST
  Included in Virtual Experience

3:00pm EST

CHAIRPERSON'S CLOSING REMARKS
Speakers
avatar for Dawn Niccum

Dawn Niccum

Executive Director, QA and Compliance, INSEPTION GROUP
With over 25 years of Clinical Operations and Quality Assurance pharmaceutical experience, Dawn provides clients a unique perspective of efficiency, speed, and compliance. She is an experienced leader in clinical compliance, SOP development, computer system validation, quality document... Read More →

Wednesday December 7, 2022 3:00pm - 3:15pm EST
  Included in Virtual Experience
 
Filter sessions
Apply filters to sessions.
Monday, December 5
Tuesday, December 6
Wednesday, December 7
  • In-Person Experience ONLY
  • Included in Virtual Experience
  • Networking