loader
 

Risk-Based Supply Chain Validation & Verification

Loading Events

« All Events

July 16

Virtual, United States

The time for implementing and maintaining a risk-based, validated supply chain has never been greater. Navigating the critical elements and vulnerabilities during pandemic operations is now the new normal as the life science industry faces the Increased risk of regulatory non-compliance, order deficiencies, product shortages, shipping challenges and much more. This seminar teaches the procedures and offers the tools and techniques to ensure a validated, risk-based supply chain that ensures business continuity during a pandemic and normal operations. 

 

Top Reasons to Attend: 

  1. Maintain the validated state across the entire supply chain 
  2. Understand cause-and-effect between supply chain and the validated state 
  3. Learn validation boundaries after PPQ – From final packaging through transportation  
  4. Manage transportation qualification and cold-chain operations effectively   
  5. Understand roles and responsibilities across manufacturing and distribution networks 
  6. Review current regulatory requirements for supplier audits  
  7. Classify suppliers based on a risk and nature of materials, services or components  
  8. Create an audit checklist) during a supplier audit – Know of key areas to cover 
  9. Review of activities to be performed after completion of an audit  
  10. Mitigate suppliers unacceptable and potential impact on other quality systems 
  11. Implement risk management procedures and complete assessment reports  
  12. Understand the interrelationship with change control in maintaining a validated state  
  13. Conduct quality investigations and develop an effective CAPA System 
  14. Revisit concurrent validation rationale and justification during COVID-19 times 
  15. Develop a disaster preparedness plan to support business continuity  
  16. Link risk-based verification to supply chain impact 
  17. Learn how to develop a network that supports quality culture  
  18. Manage disruptors and adjust as necessary 
  19. Launch mitigation strategies based on risks 
  20. Conduct periodic evaluation for adaptation and continuous improvement 

 

Personnel in the Following Environments Should Attend:

  • Supply Chain
  • Validation
  • Quality
  • Logistics
  • Transportation
  • Distribution
  • Serialization
  • Sourcing and Procurement
  • Operations
  • Compliance
  • Manufacturing
  • Quality
  • Regulatory Affairs
  • Validation

 

Agenda

  • 10:15 AM EST
    Webinar Host Opening Remarks
    Howard Wilensky, Executive Director, KENX
  • 10:30 AM – 12:00 PM EST
    Supply Chain — Maintain the Validated State
    Gerardo Gomez, Director of Validation Services, PharmaLex
  • 12:00 PM – 12:15 PM EST
    BREAK
  • 12:15 PM– 1:45 PM EST
    Supply Chain Risk Management — Implementing a Risk-based Approach
    Ann McGee, Quality, GxP Compliance & GxP Training Services, PharmaLex
  • 1:45 PM – 2:00 PM EST
    BREAK
  • 2:00 PM – 3:30 PM EST
    Develop a Preparedness Plan to Support Business Continuity
    Kim Huynh-Ba, Managing Director, Pharmalytik Consulting
  • 3:30 PM – 3:45 PM EST
    BREAK
  • 3:45 – 5:15 PM EST
    Supplier Audits — A Migraine for Many and Some Remedies to Get Through Them
    Ken Christie, COO, VTS Consultants, Inc.
  • 5:15 PM EST
    Close of Virtual Training

Faculty

  • Gerardo Gomez, Director of Validation Services, PharmaLex

    Dr. Gerardo Gomez has more than 25 years of experience in the Pharmaceutical and Biotechnology industries. He has held technical and leadership roles in the areas of validations, technical transfer, operations, and regulatory compliance in major biopharmaceutical companies. He has been part of the PharmaLex leadership team for the last nine years, conducting both strategic and tactical (execution) projects, while playing key roles for PharmaLex clients – big and small – and for PharmaLex talent and business development initiatives. Gerardo earned his Ph.D. in Pharmaceutical Sciences from the University of Michigan, after graduating magna cum laude from the Chemical Engineering department at The University of Puerto Rico.
  • Kim Huynh-Ba, Managing Director, Pharmalytik Consulting

    Kim Huynh-Ba is the Managing Director of Pharmalytik, LLC, a consulting and training organization. She has almost 30-year experience in the Quality system, strategic drug development, and stability sciences. She is a Council of Expert of US Pharmacopeia (2015-2020), where she chairs the Chemical Medicines IV Expert Committee. She is also a member of the USP Organic Impurities of Drug Products Expert Panel. Kim was the chair of the USP Good Documentation Practices Expert panel. Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology, where she teaches Quality Audit, GMPs, ICH quality guidelines, and Pharmaceutical Analysis. She is the editor of the two well-known stability handbooks-“Handbook of Stability Testing of Pharmaceutical products” and “Stability Testing to support Global Markets.” She is also completing a new manuscript entitled “Analytical chemistry: A handbook of Pharmaceutical GMP Laboratories.”
  • Ken Christie, COO, VTS Consultants, Inc.

    Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations. Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third-party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.
  • Ann McGee, Quality, GxP Compliance & GxP Training Services, PharmaLex

    Over 30 years work experience within the pharmaceutical industry, as both a regulator and a consultant. Her experience spans quality and regulatory compliance (GxP) across the product lifecycle. Has inspected nationally and internationally on behalf of the EMEA for GxP compliance and has advised on best practice guidance for the pharmaceutical industry. In her current role Ann leads PharmaLex’s global Quality Management and Compliance (QMC) practice.

Sponsors

  • Pharmalex

    PharmaLex is one of the largest providers of Quality and Validation Services, Regulatory Affairs, Development Consulting and Pharmacovigilance & Risk Management worldwide. Our teams of experts offer a comprehensive portfolio of regulatory compliance services to support pharmaceutical, biopharmaceutical, and medical device organizations throughout the entire product lifecycle.
    Website: https://www.pharmalex.com/

Venue

Details

Date:
July 16
Event Category:

Venue

Remote
Virtual, United States

Pricing & Registration

opt-in below for event updates