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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 A-tea and implementing a best-in-class procedure that impress 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 to 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
    Regulatory Intelligence—Staying Up to Speed on Regulatory Thinking
  • 2:15
    Observations and Responses—Interpreting and Responding to Regulatory Concerns
  • 3:00
    Afternoon Refreshment Break
  • 3:30
    Hot Topics for Regulatory Inspections (Data Integrity, Metrics, QRM)
  • 4:15
    Staying Compliant by Knowing and Understanding Warning Letter Trends
  • 5:00
    KENX/Temple Scholarship Award & Welcome Reception
  • 7:00
    Coffee and Lite Breakfast
  • 7:30 – 08:15
    Select Between Knowledge Exchange Sessions (1-2)
  • (1)
    Internal Auditor Master Class
    • Share and overcome project management challenges
  • (2)
    Perform an Effective Quality Assessment
  • 8:30 – 12:00
    Select Between Knowledge Exchange Sessions (A-C)
  • (A)
    Bio/Pharmaceutical Audit Management Boot Camp
    • Audit planning (understanding your stakeholders needs, developing your audit team and audit strategy, auditing for compliance and identifying OFIs, interpreting applicable regulations and standards) • Tools and techniques: selecting your audit approach (QMS, product, quality agreements, cradle to grave, focus audits, etc.), root cause analysis for auditors, interview techniques • Best practices and audit handbook • Leveraging and Influencing your peers and stakeholders (including conflict management) • Project management skills for auditors
  • (B)
    The Medical Device Single Audit Process – Manufacturer Case Study
  • (C)
    Build and Manage a Change Control Program that is Inspection Ever-Ready
  • 12:00
    Focus Group Luncheons (3-5)
  • (3)
    ICH and Why You Should Care
    • A high-level overview of all quality guidances and their requirements
  • (4)
    Build and Manage a Contamination Control Program that is Inspection Ever-Ready
  • (5)
    Recruit Personnel for Your Change Control Committee
  • 1:15 – 2:45
    Select Between Knowledge Exchange Sessions (6-8)
  • (6)
    Inspection Readiness—What It Mean and How Can You Achieve It
    • Inspection management playbook • Mock inspections focused on GMP questions that cause sleepless nights
  • (7)
    Build and Manage a Data Integrity Program that is Inspection Ever-Ready
  • (8)
    Implement Risk Management and Impact Assessments for Change Control
  • 2:45
    Afternoon Refreshment Break
  • 3:15 – 4:45
    Select Between Knowledge Exchange Sessions (9-11)
  • (9)
    Create a “Communication with Inspectors” Playbook
  • (10)
    Build and Manage a Validation/Qualification Program that is Inspection Ever-Ready
  • (11)
    Change Control and Configuration Management
  • 4:45
    Close of Day Two
  • 7:00
    Coffee and Lite Breakfast
  • 7:30 – 8:15
    Select Between Knowledge Exchange Breakfasts (12-14)
  • (12)
    Discover Documentation Practices and Effective Quality Management Software
  • (13)
    Build and Manage a Deviation Management Program that is Inspection Ever-Ready
  • (14)
    Identification and Classification of Changes
  • 8:30 – 10:00
    Select Between Knowledge Exchange Sessions (15-17)
  • (15)
    Risk-Based Auditing
    • What is risk-based auditing? • When and how to use RB auditing to your advantage (includes risk calculation tool for audit planning, timing of audits, utilizing regulatory trends)
  • (16)
    Build and Manage a Quality Risk Management (QRM) Program that is Inspection Ever-Ready
  • (17)
    Managing Change Control Globally – A Case Study
  • 10:00
    Mid-Morning Refreshment Break
  • Select Between Knowledge Exchange Sessions (18-20)
  • (18)
    FDA “Live Review” Inspections
    • FDA request to browse through repository folders, request to obtain copy of data on a USB, deletion of data, etc.) • Adapting to the new approach (quality documentation, putting your data and computer systems to the test)
  • (19)
    Build and Manage a CAPA Program that is Inspection Ever-Ready
  • (20)
    Post Approval Change Control Protocols
  • 12:00
    Focus Group Luncheons (21-22)
  • (21)
    Advanced Audit Professional Master Class
    • Program Management for Internal Auditors
  • (22)
    Dealing with Software Changes
  • 1:15 – 2:45
    Select Between Knowledge Exchange Sessions
  • (23)
    Internal Audit Program – Building a Sustainable and Effective Program, Boosting Compliance, and Increasing Value to the Organization
    • RB audit planning, timing of your internal audits with upcoming inspections, creating an escalation process, identifying and capturing the issues and root causes before the Inspector finds it
  • (24)
    Build and Manage a Complaint Handling Program that Is Audit and Inspection Ever-Ready
  • (25)
    Handling Deviations in Change Control Processes
  • 2:45
    Afternoon Refreshment Break
  • 3:15 – 4:45
    Select Between Knowledge Exchange Sessions (26-27)
  • (26)
    Implement Quality Metrics and Quality Culture Programs
  • (27)
    Perform a Quality System Gap Assessment
  • 4:30
    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.”
  • Faculty

  • Coming Soon!

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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