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Strategies for Quality Management and FDA Compliance

September 26-27, 2017
  • Cambridge, MA

Bio/Pharma organizations and their contracted suppliers need to fully understand and adhere to all the latest FDA regulations. Effective internal and external audits and post-audit procedures are key to ensuring quality assurance and compliance. IVT’s Supplier Quality and Audit conference provides attendees with strategies for preventing 483s and any accompanying observations or warning letters, inadequate supplier control records and documentation, infrequent monitoring and supplier criteria, operational integration and much more.

Need Help Streamlining Approval to Attend? Download a justification letter today
ATTEND This forum is a master class in auditing and supplier quality
LEARN Key procedures for NAT & INTL suppliers and FDA compliance
TAKE-AWAY SOPs for qualifying vendors, streamlining audits, handling 483s

IN-DEPTH SESSIONS AND DISCUSSIONS INCLUDE:

  • A Practical Application of Supplier Risk Assessment
  • Risk-Based Supplier Qualification and Management —
    A Tool for Preventing FDA Enforcement Actions
  • Assessing the Impact of Supplier Changes and
    Supplier Change Notifications on Current Products
  • FDA Lifecycle Approach to Process Validation —
    Application to Supplier Audits and Quality Systems
  • Auditing & Qualifying Sterile Compounding Facilities — A “How-to Guide”
    and In-Depth Discussion on the Technical Aspects of The Audit
  • Proper Audit Planning to Ensure Maximum Effectiveness and Efficiency

KEY TAKE-AWAY’S INCLUDE:

  • Plan, conduct and report efficient and effective supplier audits
    for successful supplier oversight and management
  • A logical, thorough and consistent approach to
    auditing multiple applications
  • Perform a thorough impact assessment of supplier or
    incoming material changes
  • Insights into current regulatory inspection trends and sources
    to develop your own compliance landscape monitoring program

September 26-27, 2017 Royal Sonesta Boston Cambridge, MA

Supplier Quality and Audit

Strategies for Quality Management and FDA Compliance

Bio/Pharma organizations and their contracted suppliers need to fully understand and adhere to all the latest FDA regulations. Effective internal and external audits and post-audit procedures are key to ensuring quality assurance and compliance. IVT’s Supplier Quality and Audit conference provides attendees with strategies for preventing 483s and any accompanying observations or warning letters, inadequate supplier control records and documentation, infrequent monitoring and supplier criteria, operational integration and much more.

Need Help Streamlining Approval to Attend? Download a justification letter today
ATTEND This forum is a master class in auditing and supplier quality
LEARN Key procedures for NAT & INTL suppliers and FDA compliance
TAKE-AWAY SOPs for qualifying vendors, streamlining audits, handling 483s

IN-DEPTH SESSIONS AND DISCUSSIONS INCLUDE:

  • A Practical Application of Supplier Risk Assessment
  • Risk-Based Supplier Qualification and Management —
    A Tool for Preventing FDA Enforcement Actions
  • Assessing the Impact of Supplier Changes and
    Supplier Change Notifications on Current Products
  • FDA Lifecycle Approach to Process Validation —
    Application to Supplier Audits and Quality Systems
  • Auditing & Qualifying Sterile Compounding Facilities — A “How-to Guide”
    and In-Depth Discussion on the Technical Aspects of The Audit
  • Proper Audit Planning to Ensure Maximum Effectiveness and Efficiency

KEY TAKE-AWAY’S INCLUDE:

  • Plan, conduct and report efficient and effective supplier audits
    for successful supplier oversight and management
  • A logical, thorough and consistent approach to
    auditing multiple applications
  • Perform a thorough impact assessment of supplier or
    incoming material changes
  • Insights into current regulatory inspection trends and sources
    to develop your own compliance landscape monitoring program

September 26-27, 2017 Royal Sonesta Boston Cambridge, MA