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VALIDATION AND GMP SEMINAR SERIES

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November 11 - November 12

San Juan, Puerto Rico

Knowledge Exchange Network (KENX) is very excited to announce their one day training courses is headed to Puerto Rico this Fall. This seminar series is the perfect training camp for those wishing to enhance their professional development in the validation and GMP environment. These courses are specifically designed for the Puerto Rico life science industry. Join your colleagues in San Juan this November and walk away with the innovative processes and tools that will have immediate impact in your organization..

 

4 Training Courses Overflowing with Rich Content and Tangible Takeaways for the Validation and GMP Universe

 

Process Validation & Continued Verification – November 11

  • Develop, Implement and Verify a Risk-based Process Validation approach
  • Master the Validation Master Plan (VMP)
  • Conduct Risk-based Revalidations and Periodic Reviews
  • Know the requirements and best processes for documentation

 

Computer System & Data Integrity Validation – November 11

  • Master the Key Components to Build and Maintain an Inspection-proof Program
  • Develop an IT Infrastructure and Cloud Environments
  • Construct a Program from the Ground Up
  • Prepare for and Perform CSV and Data Integrity Audits and Inspections

 

Cleaning Validation – November 12

  • Understand Key Elements to a Successful Program
  • Establish Cleaning Residue Limits and Acceptance Criteria
  • Validate Cleanroom, Disinfection and Environmental Monitoring Processes
  • Receive a Cleaning Validation Assessment Checklist Example

 

Preparing for and Handling FDA Inspections – November 12

  • Conduct Internal Audits and Mock Inspections
  • Learn Best Practices for Hosting an Inspection
  • Facilitating the Close-out meeting and responses
  • Know How To Respond to Inspectional Findings

 

Personnel In The Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • GMP and Validation Auditors
  • Regulatory and Compliance
  • Facility Management
  • Manufacturing
  • Laboratory

 

This event is also appropriate for business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the life science environment.

Agenda

  • 7:30 AM
    Conference Registration
    Coffee and Continental Breakfast
  • 8:15 AM
    Chairperson’s Opening Remarks
  • 8:30 AM
    Compliance Intelligence Town Hall – Stay Up to Speed with FDA Regulatory Thinking
  • 10:00 AM
    Networking Refreshment Break
  • 10:30 AM
    The Validation Master Plan (VMP) – Plans that Impress FDA Investigators
  • 11:15 AM
    Apply Quality Risk Management (QRM) throughout Your Quality System – Where, When and How
  • 12:00 PM
    Lunch & Learns (1 - 2)
  • 1
    FDA Guidance on Quality Agreement for Contract Manufacturing
  • 2
    Quality Risk Management Tools Used in Quality Systems and Validation
  • 1:15 - 4:45 PM
    Select Between Execution and Master Planning Workshops (A-B)
  • A
    Successful Implementation of a 3-Stage Process Validation Program
  • B
    Develop, Implement and Maintain a Risk-Based Computer and Software Validation Program
  • 4:45 PM
    Networking Welcome Reception
  • 7:30 AM
    Coffee and Lite Breakfast
  • 8:30 AM - 12:00 PM
    Select Between Execution and Master Planning Workshops (C-D)
  • C
    FDA Inspections – Preparation and Management Techniques that Impress Investigators
  • D
    Data Integrity Governance and Planning - Conceptualization through Program Implementation
  • 12:00 PM
    Lunch & Learns (3-4)
  • 3
    FDA Guidance on Quality Agreement for Contract Manufacturing
  • 4
    Audit Trail Review for Data Integrity
  • 1:15 - 4:30 PM
    Select Between Execution and Master Planning Workshops (E-F)
  • E
    Risk-Based Cleaning Validation – Key Elements to a Successful Program
  • F
    Develop and Implement a Change Control Program
  • 4:30 PM
    Close of Conference

Faculty

  • Maridalia Torres, Senior Regulatory Compliance Advisor

    Maridalia Torres served as Director of the Food and Drug Administration’s San Juan District Office and was part of the Office of Regulatory Affairs Senior Management from October 2006 to January 2018 with responsibility over FDA's operations in Puerto Rico and US Virgin Islands. After ORA's Program Alignment in 2017, she also served as Program Division Director for the Office of Human and Animal Food Operations Division IV East with oversight of the human and animal food regulatory operations in Florida, Puerto Rico, and the US Virgin Islands.
  • Patrick Mains, PMP, Principal Quality Engineer, Global Quality Risk Management

    Patrick is responsible for the design, deployment, realization and governance of a harmonized GMP compliant Quality Risk Management (QRM) Program for the Roche global network. He routinely provides training, leadership, QRM expertise and facilitation for complex risk management efforts. Patrick has a background in Pharmaceutical Quality Control which he leverages to support the organization in QRM implementation.
  • Gerardo Gomez, Senior Business Development Manager, ECHO Consulting Group, A PharmaLex Company

    Gerardo is a dynamic and accomplished leader, with over 25 years of experience in the Pharmaceutical and Biotechnology industries. He is recognized as a Subject Matter Expert in the areas of validations, technology transfer, investigations/CAPA systems, sterile product manufacturing, aseptic processes, and lyophilization. Gerardo has held positions at senior manager and director levels, complimenting his solid technical and scientifi c background with his natural people skills to effectively lead people and teams to success. Gerardo is known for his superb communications skills – both during public presentations and in writing – skills that he has used to consistently motivate people to action during ambitious and challenging projects. Gerardo graduated Magna Cum Laude from the Chemical Engineering department at the University of Puerto Rico, and later earned his Ph.D. in Pharmaceutics from the University of Michigan.
  • Roque Redondo, VP Automation & Business Development, USA Operations, Mirus Consulting Group

    Mr. Roque Redondo has close to 30 years of experience including international experience in the validation, QA, engineering, compliance and regulatory affairs in the life science environment. He was part of the senior management team during the implementation of the remediation activities related to Schering-Plough Consent Decree. His experience includes Data Integrity, operations, serialization, validation, QA, engineering and technical services. Mr. Redondo has attended to over 10 different courses related to Data Integrity as well as he has written 5 articles related to this topic. He has a nice blend of experience, including process and cleaning procedures, that help him understand the importance of manufacturing operations without jeopardizing the quality of the products with strong management skills.
  • Chris Wubbolt, Principal Consultant, QACV Consulting, LLC

    Chris Wubbolt is a Certifi ed Six Sigma Black Belt, has a Masters Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering. Chris was the previous President of both the New England Region Chapter Society of Quality Assurance (NERCSQA) and the MidAtlantic Region Society of Quality Assurance (MARSQA), and is currently the chairperson of the MARSQA computer validation committee.
  • Gamal Amer , 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.

Sponsors


  • mîrus consulting group was founded in Humacao, PR and since its beginning in 2001 has worked to become a pioneer company in the market place. mîrus possess extensive industry experience, commitment to the delivery of high quality service to our clients, and a proven experienced management team. We offer a commitment of meeting every goal no matter the size of the project. We will address every project with the same intensity for optimum outcomes.
    Website: https://www.miruspr.com/
  • We provide consulting and educational services using a group of committed, compliance wise and highly educated professionals with vast start-up and sustaining operations experience.

    Website: https://www.echo-cg.com/
  • QACV offers comprehensive quality assurance, compliance, and computer validation consulting services to meet your regulatory needs. We provide professional consulting services to FDA regulated life science industries and use proven methodologies to achieve sustainable compliance for your organization.
    Website: http://www.qacvconsulting.com/
  • Global Leader in Paperless Validation.
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/

Partners

    More Information To Follow Soon

Venue

Details

Start:
November 11
End:
November 12
Event Category:

Venue

AC Hotel San Juan
1369 Ashford Avenue
San Juan, 00907 Puerto Rico
+ Google Map
Phone:
+1 787-827-7280
Website:
https://achotels.marriott.com/hotels/ac-hotel-san-juan-condado

Pricing & Registration

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