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Quality Risk Management

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August 21 @ 12:00 PM - August 23 @ 4:30 PM

Philadelphia, United States

Make Key Decisions Based on an Effectively Managing Risks in Your Quality System

 

Risk management is a key component to your Quality Management System, a regulatory requirement and one that has critical impact on your organization. KENX is excited to announce a conference the can dramatically affect your strategy surrounding your risk management program. KENX’s Quality Risk Management conference provides the knowledge and tools to develop, implement and maintain best-in-class procedures that impresses FDA investigators, benefits your organization and expands your professional development. This program guides you through the process of evaluating, managing and mitigating risks to your quality system.

 

 

Top 10 Reasons to Attend:

  • Regulatory intelligence – Stay up to speed on regulatory thinking
  • Know ICH guidelines and why you should care
  • Discover the most under-utilized QRM tool in industry
  • Minimize subjectivity is risk assessments
  • Present your QRM program to an inspector
  • Learn how to structure QRM training
  • See Bayer’s journey toward a robust QRM program
  • Go beyond FMEA – QRM tools you should be using (but aren’t)
  • Create custom risk tools/risk-based approaches
  • Go well beyond ICH Q9 and the basics

 

Personnel in the Following Environments Should Attend:

  • QA/QC
  • Risk management
  • Regulatory affairs
  • Compliance and auditing
  • Internal auditing
  • Quality engineers
  • Manufacturing
  • Laboratory

 

 

 

This event is also appropriate to business development and sales managers that offer innovative solutions for change control, risk management, statistics and validation.

Agenda

  • 12:00
    Conference Registration
    Coffee and Lite Snacks On-the-Go
  • 1:15
    Chairperson’s Opening Remarks
  • 1:30-5:00
    General Sessions
  • Audits | Risk | Change
  • Regulatory Intelligence—Staying Up to Speed on Regulatory Thinking
    Karyn Campbell, Director, Investigations Branch II, Division of Pharmaceutical Quality Operations, U.S. Food and Drug Administration (FDA)
  • Staying Compliant by Knowing and Understanding Warning Letter Trends
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories – Diagnostics Division
  • WHO GMP Global Inspection Readiness
    Kim Huynh-Ba, Executive Director, Pharmalytik
  • ICH Guidance and Why You Should Care
    Gamal Amer, Ph.D., Principal, Premier Compliance Services, Inc.
  • 5:00
    KENX/Temple Scholarship Award & Welcome Reception
  • 7:00
    Coffee and Lite Breakfast
  • 7:30-8:15
    Select Between Knowledge Exchange Sessions
  • Audits & Inspections
    Auditing Contract Manufacturing Organizations (CMOs)
    Loren Kim, Principal Quality Systems Consultants, QSI Consulting, LLC
  • Risk Management
    ICHQ9 – A Foundation and Resource for Success
    Jon Williams, Global Quality Risk Management, Sanofi
  • Change Control
    Introduction to Change Control Regulation: What’s Required
    Alan Golden, MS, Principal Quality Professional, Product Quality
  • 8:30 – 12:00
    Select Between Knowledge Exchange Workshops
  • Audits & Inspections
    Bio/Pharmaceutical Audit Management Boot Camp
    Mony Clark, Senior Specialist, QA Site Compliance, Bayer Pharmaceuticals
  • Risk Management
    The Most Under-Utilized QRM Tool in Industry
    Amanda B. McFarland, Senior Consultant, ValSource, LLC
  • Change Control
    Build and Maintain an Inspection-Ready Change Control Program
    Kim Huynh-Ba, Executive Director, Pharmalytik
  • 12:00
    Lunch and Learn Sessions
  • Audits & Inspections
    Common Audit Challenges
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories – Diagnostics Division
  • Risk Management
    Pitfalls in Quality Risk Management – Top Ten Most Common Errors
    Kelly Waldron, Senior Consultant, Valsource and Regulatory Science Researcher, Dublin Institute of Technology
  • Change Control
    The Five Most Important Challenges Faced in Implementing Change Control in Pharmaceutical Manufacturing
    Gamal Amer, Ph.D., Principal, Premier Compliance Services, Inc.
  • 1:15 – 2:45
    Select Between Knowledge Exchange Sessions
  • Audits & Inspections
    Internal Audit Program –Boost Compliance and Increase Value to the Organization
    Mony Clark, Senior Specialist, QA Site Compliance, Bayer Pharmaceuticals
  • Risk Management
    QRM Master Class - Ask the Expert
    Kelly Waldron, Senior Consultant, Valsource and Regulatory Science Researcher, Dublin Institute of Technology
  • Change Control
    Change Control for Computer Systems: Software Upgrades
    Chinmoy Roy, Data Integrity and CSV SME, Consultant
  • 2:45
    Afternoon Refreshment Break
  • 3:15 – 4:45
    Select Between Knowledge Exchange Sessions
  • Audits & Inspections
    So, You’re Not Auditing Data Integrity Yet (But You Should Be)
    Chinmoy Roy, Data Integrity and CSV SME, Consultant
  • Risk Management
    Bias, Heuristics, Risk Management, Oh My! The Human Factor Impact
    Lori Richter, Senior Consultant, ValSource
  • Change Control
    Create Change Plans for Change Control: What Works and What Doesn’t
    Alan Golden, MS, Principal Quality Professional, Product Quality
  • 4:45
    Close of Day Two
  • 7:00
    Coffee and Lite Breakfast
  • 7:30-8:15
    Between Knowledge Exchange Breakfasts
  • Audits & Inspections
    Inspection Readiness—How to Ensure You’re Ready for Your Next Health Authority Inspection
    Mary Farbman, Executive Director, Compliance Remediation and Support, Merck
  • Risk Management
    QRM Open Forum: Benchmark with Your Peers
    Kelly Waldron, Senior Consultant, Valsource and Regulatory Science Researcher, Dublin Institute of Technology
  • Change Control
    Handling Automatic Software Upgrades in Cloud Systems (XaaS)
    Chinmoy Roy, Data Integrity and CSV SME, Consultant
  • 8:30 – 12:00
    Select Between Knowledge Exchange Workshops
  • Audits & Inspections
    What Would You Do? Inspection Prep Think Tank
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • Risk Management
    Preparing for a QRM focused Inspection
    Ghada Haddad- Executive Director, Global cGMP & Auditing Organization, Merck and Darshana Patel, Associate Director Quality Risk Management Center of Excellence, Merck
  • Change Control
    Presenting Your Change Control Program to an Inspector
    Joseph Zec, Associate Director, CSV and Compliance, Shire plc
  • 12:00
    Lunch and Learn Sessions
  • Audits & Inspections
    Transition from QA Police to Compliance Partner
    Loren Kim, Principal Quality Systems Consultants, QSI Consulting, LLC
  • Risk Management
    A Case Study Journey towards a Robust QRM Program
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • Change Control
    Post Approval Change Control Protocols
    To Be Announced
  • 1:15 – 2:45
    Select Between Knowledge Exchange Sessions
  • Audits & Inspections
    FDA “Live Review” Inspections
    Lisette Gilchrist, Director, Quality Systems and Compliance, Bayer Pharmaceuticals
  • Risk Management
    Successful FMEA Training: Play with a Purpose
    Jon Williams, Global Quality Risk Management, Sanofi
  • Change Control
    Implementing a Global Change Control Process – A Case Study
    Joseph Zec, Associate Director, CSV and Compliance, Shire plc
  • 2:45
    Afternoon Refreshment Break
  • 3:15 – 4:45
    Select Between Knowledge Exchange Sessions
  • Audits & Inspections
    Observations and Responses – Interpret and Respond to Regulatory Concerns
    Mary Farbman, Executive Director, Compliance Remediation and Support, Merck
  • Risk | Change
    Implement Risk Management in the Change Control Processes
    Gamal Amer, Ph.D., Principal, Premier Compliance Services, Inc.
  • 4:45
    Close of Conference

Faculty

  • Advisory Board Members

  • Mony Clark, Senior Compliance Specialist and Lead Auditor, Bayer Pharmaceuticals

    Ms. Mony Clark is a Senior Compliance Specialist and Lead Auditor at Bayer Pharmaceuticals where she is responsible for managing the Internal Audit Program. In addition, as a qualified Risk Facilitator, Ms. Clark supports risk assessments and offers her specialized assistance in external audits for Supplier Management. In Mrs. Clark's experiences in both Medical Devices and Pharmaceutical industries, she has guided companies through gap assessments, transitioning them from research and development to GMP compliant manufacturing facilities. For the past 12 years, Mrs. Clark has managed Quality Systems, and audit programs, demonstrating a proven track record of leading several companies through successful inspections, including Pre-Approval Inspections and ISO accreditations.
  • Kelly Waldron, Senior Consultant, Valsource and Regulatory Science Researcher, Dublin Institute of Technology (DIT)

    Kelly Waldron is an industry expert in Quality Risk Management (QRM). She is currently a Senior Consultant with Valsource and is pursuing her PhD in QRM from the Dublin Institute of Technology. She has over fourteen years of experience in various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, with nine years focused on QRM. Kelly has authored several industry and academic papers on QRM and most recently, she served as a member of the PDA Task Force that recently released PDA Technical Report 54-5, “QRM in Design, Commissioning, and Qualification.”
  • GMP University Speakers

  • Gamal Amer, Ph.D., Principal, Premier Compliance Services, Inc.

    Dr. Amer, a chemical engineer by training, has 40 years-experience in the pharmaceutical and related industries. He has held senior management positions with leading pharmaceutical, consumer products, and engineering consulting companies. His experience includes comprehensive process design in bulk pharmaceutical chemicals manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing, and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation. He has lectured extensively in the US, Europe, Asia, and the Middle East and taught many courses on subjects such as controlled release technology, GMP trends, Validation and Change Control, and implication of GMP compliance on process and facility design in the biotechnology industry.
  • Karyn Campbell, Director, Investigations Branch II, Division of Pharmaceutical Quality Operations, U.S. Food and Drug Administration (FDA)

    Karyn is the Director of Investigations Branch and the Pre-Approval Inspection Manager for FDA’s Philadelphia District Office. Karyn has been with FDA in Philadelphia for 25 years. She is responsible for implementing and maintaining Investigations Branch’s quality assurance program and monitoring the Branch’s human drug establishment registration, drug quality reporting system, and field alert programs. Prior to her current position, she spent 11 years as a Compliance Officer, 5 years as an Investigator, and 3 years working in what is now the Central Regional Office. Karyn is a certified Level II drug investigator. She provides training in FDA law, evidence development, pharmaceutical inspections, and compliance issues internally at FDA and to industry. She has been a guest lecturer at several academic institutions including Temple University, Dickinson School of Law, and Widener University School of Law. She is currently an Adjunct Associate Professor at Temple University’s School of Pharmacy, where she co-teaches a course in Pre-Approval Inspections in the Quality Assurance/Regulatory Affairs graduate degree program. She holds a B.S. in Biology from Gwynedd-Mercy College.
  • Mony Clark, Senior Compliance Specialist and Lead Auditor, Bayer Pharmaceuticals

    Ms. Mony Clark is a Senior Compliance Specialist and Lead Auditor at Bayer Pharmaceuticals where she is responsible for managing the Internal Audit Program. In addition, as a qualified Risk Facilitator, Ms. Clark supports risk assessments and offers her specialized assistance in external audits for Supplier Management. In Ms. Clark's experiences in both Medical Devices and Pharmaceutical industries, she has guided companies through gap assessments, transitioning them from research and development to GMP compliant manufacturing facilities. For the past 12 years, Ms. Clark has managed Quality Systems, and audit programs, demonstrating a proven track record of leading several companies through successful inspections, including Pre-Approval Inspections and ISO accreditations.
  • Mary Farbman, Executive Director, Compliance Remediation and Support, Merck

    Dr. Farbman is responsible for compliance support, inspection readiness, and inspection response formulation assistance at Merck’s human health manufacturing facilities. She spent six years at FDA/CDER’s Office of Compliance, where she was responsible for authoring and reviewing warning letters and other compliance documents, conducting microbiological reviews of therapeutic protein manufacturing processes, and performing pre-license inspections of BLA products. In industry, she has worked at both the site and global levels in various compliance and auditing roles as well as in the R&D arena. Her areas of expertise include biotechnology and sterile products and analytical techniques. She holds a doctorate degree in biological chemistry from MIT, where she researched enzyme kinetics of bacterial proteases.
  • Lisette Gilchrist, Director, Quality Systems and Compliance, Bayer U.S. LLC

    Lisette Gilchrist is an experienced Quality professional with over fifteen years of experience throughout Quality including; Intermediate Product Release, Documentation, Training and Quality Risk Management. She routinely hosts regulatory inspections and has a demonstrated track record for leading and implementing sustainable, compliant, efficient (and fun) Quality Systems initiatives in inspection readiness, quality culture and regulatory intelligence. Lisette has also served as a Faculty Instructor for the Parenteral Drug Association (PDA) providing training on leading change and quality management leadership.
  • Alan Golden, Principal, Design Quality Consultants, LLC

    Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations. Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years. Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance. Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.
  • Ghada Haddad, Executive Director, Global cGMP and Auditing Organization, Merck

    Ghada Haddad is currently an Executive Director, leading the Global cGMP and Compliance Auditing Organization at Merck & Company. Prior to that she was the Head of the Global Quality Risk Management Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree and an MBA with over 22 years of experience, working in the Biotech and Pharmaceutical industries in the areas of Quality Risk Management (QRM), Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, change control and validation.
  • Kim Huynh-Ba, Executive Director, Pharmalytik

    Kim is an accomplished author and speaker of the compliance and quality areas, both domestic and internationally. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010) published by Springer. She is currently working on a manuscript of “Analytical Chemistry: an introduction to pharmaceutical analysis,” expecting to be available late 2018. She can be contacted at kim.huynhba@pharmalytik.com.
  • Loren Kim, Principal Quality Systems Consultants, QSI Consulting, LLC

  • Amanda B. McFarland, Senior Consultant, ValSource, LLC

  • Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories – Diagnostics Division

    Erik Muegge’s experience is focused on FDA and related regulated environments for pharmaceuticals, consumer products, and medical devices. His specific areas of work include Quality Systems, operations, outsourcing, process re-engineering, project management, product development life cycle (R&D through Launch) and validation. Erik has; led efforts in several PPC (Production and Process Controls) areas; harmonized validation activities globally across seven sites; audited quality systems of strategic partners; been recognized as a global SME resulting in three industry awards.
  • Darshana Patel, Associate Director Quality Risk Management Center of Excellence, Merck

  • Lori Richter, Senior Consultant, ValSource

  • Chinmoy Roy, Data Integrity and CSV SME, Consultant

    Chinmoy Roy is an experienced biopharmaceutical consultant with subject matter expertise in CSV, Data Integrity, CFR 21 Part 11, Annex 11 and manufacturing process automation systems. He is a member of ISPE’s Data Integrity Special Interest Group (S.I.G). His presentations blend his field experience to highlight the intricacies of implementing regulations. Chinmoy has a bachelor’s degree in Electrical Engineer and a Masters degree in Computer Science.
  • Kelly Waldron, Senior Consultant, ValSource; and, Member, Pharmaceutical Regulatory Science Team (PRST), Dublin Institute of Technology

    Kelly Waldron is an industry expert in Quality Risk Management (QRM). She is currently a Senior Consultant with Valsource and is pursuing her PhD in QRM from the Dublin Institute of Technology. She has over fourteen years of experience in various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, with nine years focused on QRM. Kelly has authored several industry and academic papers on QRM and most recently, she served as a member of the PDA Task Force that recently released PDA Technical Report 54-5, “QRM in Design, Commissioning, and Qualification.”
  • Jon Williams, Global Quality Risk Management, Sanofi

    Jon Williams is part of the Sanofi Global Quality Risk Management (QRM) team responsible for the deployment and integration of the QRM program initially created at Genzyme to the broader Sanofi organization. His responsibilities include tool development, training, mentoring and performing surveillance assessments to measure risk maturity at the manufacturing site level. Prior to entering the world of risk, Jon was Quality Assurance Manager at a Genzyme Cell Therapy Unit.
  • Joseph, Zec, Compliance Leader, Shire

    Software Quality Professional with leadership expertise encompassing both the test and process engineering areas in both commercial and regulated industries, particularly Life Sciences. Proud to have led teams making a significant contribution to bringing high quality, successful, and compliant software products to market. Successfully built SQA departments from scratch and through joining existing teams. Introduced industry-proven best practices for SQA while exploring new, less established methods for delivering high quality software products without compromising budgets and schedules.

Sponsors

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Venue

Details

Start:
August 21 @ 12:00 PM
End:
August 23 @ 4:30 PM
Event Category:
Website:
https://www.kenx.org/events/risk-management-aug-2018-2/

Venue

Doubletree by Hilton
237 South Broad Street
Philadelphia, PA 19107 United States
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Pricing & Registration

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