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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 4

  • 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 4

  • 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 5

  • 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 5

  • 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

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Faculty

Sponsors

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Partners

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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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