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Internal Audits and FDA Inspections

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

Philadelphia, United States

Are Your Quality Systems Inspection Ever-Ready?

 

Internal Audits are an integral part of FDA inspection readiness and should ensure your Quality Systems hold water under regulatory scrutiny. This event takes a deep dive into building an internal audit program that leaves critical elements in your QS are ever-ready for any regulatory official looking at your organization under a microscope. This conference takes participants through a journey of building the and implementing a best-in-class procedure that impresses FDA investigators.

 

35 Tutorials Addressing Today’s Top Challenges

 

Internal Audits and FDA Inspections

  • Interpret and Respond to Regulatory Concerns
  • Dive into Hot Topics for Regulatory Inspections – Data Integrity, Metrics and QRM
  • Attend a Bio/Pharmaceutical Audit Management Boot Camp
  • See a Medical Device Single Audit Process (MDSAP) Manufacturer Case Study
  • Inspection Readiness – What It Mean and How Can You Achieve It
  • Create a “Communication with Inspectors” Playbook
  • Discover Documentation Practices and Superior Quality Management Software
  • Learn How to Use Risk-Based Auditing to Your Advantage
  • Build a Sustainable and Effective Internal Audit Program, Boost Compliance and Increase Value to the Organization
  • Implement Quality Metrics and Quality Culture Programs

 

Build and Manage Quality Systems Programs that are Inspection Ever-Ready

  • Validation/Qualification (lifecycle management)
  • Quality Risk Management (QRM)
  • Contamination Control
  • Internal Audit Programs
  • Data Integrity
  • Training/Qualification of Personnel
  • Deviation Management
  • Corrective and Preventive Actions (CAPA)
  • Complaint Management
  • Change Control

 

Personnel in the Following Environments Should Attend:

  • Auditors
  • QA/QC
  • Validation
  • Manufacturing
  • Laboratory Management
  • Regulatory Affairs
  • Quality Systems Management

 

This event is also appropriate for business development and sales managers that offer innovative solutions for quality systems management, document management systems; and solution providers for validation/quality departments.

 

Send Your Team!  This Event is Co-located with:

  • CHANGE CONTROL

 

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
  • Staying Compliant by Knowing and Understanding Warning Letter Trends
  • WHO GMP Global Inspection Readiness
  • ICH Guidance and Why You Should Care
  • 5:00
    KENX/Temple Scholarship Award & Welcome Reception
  • 7:00
    Coffee and Lite Breakfast
  • 7:30 – 08:15
    Select Between Knowledge Exchange Sessions
  • Audits & Inspections
    Auditing Contract Manufacturing Organizations (CMOs)
  • Risk Management
    ICHQ9 – A Foundation and Resource for Success
  • Change Control
    Introduction to Change Control Regulation: What’s Required
  • 8:30 – 12:00
    Select Between Knowledge Exchange Workshops
  • Audits & Inspections
    Bio/Pharmaceutical Audit Management Boot Camp
  • Risk Management
    The Most Under-Utilized QRM Tool in Industry
  • Change Control
    Build and Maintain an Inspection-Ready Change Control Program
  • 12:00
    Lunch and Learn Sessions
  • Audits & Inspections
    Common Audit Challenges
  • Risk Management
    Pitfalls in Quality Risk Management – Top Ten Most Common Errors
  • Change Control
    The Five Most Important Challenges Faced in Implementing Change Control in Pharmaceutical Manufacturing
  • 1:15 – 2:45
    Select Between Knowledge Exchange Sessions
  • Audits & Inspections
    Internal Audit Program –Boost Compliance and Increase Value to the Organization
  • Risk Management
    QRM Master Class - Ask the Expert
  • Change Control
    Change Control for Computer Systems: Software Upgrades
  • 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)
  • Risk Management
    Bias, Heuristics, Risk Management, Oh My! The Human Factor Impact
  • Change Control
    Create Change Plans for Change Control: What Works and What Doesn’t
  • 4:45
    Close of Day Two
  • 7:00
    Coffee and Lite Breakfast
  • 7:30 – 8:15
    Select Between Knowledge Exchange Breakfasts
  • Audits & Inspections
    Inspection Readiness—How to Ensure You’re Ready for Your Next Health Authority Inspection
  • Risk Management
    QRM Open Forum: Benchmark with Your Peers
  • Change Control
    Handling Automatic Software Upgrades in Cloud Systems (XaaS)
  • 8:30 – 12:00
    Select Between Knowledge Exchange Sessions
  • Audits & Inspections
    What Would You Do? Inspection Prep Think Tank
  • Risk Management
    Preparing for a QRM focused Inspection
  • Change Control
    Presenting Your Change Control Program to an Inspector
  • 12:00
    Lunch and Learn Sessions
  • Audits & Inspections
    Transition from QA Police to Compliance Partner
  • Risk Management
    A Case Study Journey towards a Robust QRM Program
  • Change Control
    Post Approval Change Control Protocols
  • 1:15 – 2:45
    Select Between Knowledge Exchange Sessions
  • Audits & Inspections
    FDA “Live Review” Inspections
  • Risk Management
    Successful FMEA Training: Play with a Purpose
  • Change Control
    Implementing a Global Change Control Process – A Case Study
  • 2:45-3:15
    Afternoon Refreshment Break
  • 3:15 – 4:45
    Select Between Knowledge Exchange Sessions
  • Risk | Change
  • Observations and Responses – Interpret and Respond to Regulatory Concerns
  • Implement Risk Management in the Change Control Processes
  • 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)

    (Invited)
  • 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

  • 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

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

  • 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

Sponsors

Partners

Venue

Details

Start:
August 21 @ 12:00 PM
End:
August 23 @ 4:30 PM
Event Category:
Website:
https://www.kenx.org/events/internal-audits-fda-inspections/

Venue

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

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