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Wednesday, June 27 • 12:00pm - 1:00pm
#347: Just the Right Tool: ICH E6 (R2) Compliance Tools for Small to Mid-Size Companies

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Component Type: Workshop
Level: Intermediate

The new ICH E6 (R2) guidance with it’s emphasis on risk assessment and Sponsor Oversight, has proven to be challenging for small to mid-size companies to comply .This workshop will present tools for compliance developed by the DIA GCP/QA Community.

Learning Objectives

Identify the new requirements of ICH E6 (R2); Discuss challenges to comply for small to mid-size companies; Demonstrate a simplified risk assessment tool; Demonstrate a tool for vendor oversight.

Chair

Maryrose Petrizzo, MS

Speaker

Facilitator
Sandy Mohan, PhD


Speakers
SM

Sandy Mohan

Vice President, Quality and Compliance, Immune Design
Sandy Mohan is the Vice President of Quality & Compliance at Immune Design. She has over 20 years of experience in the pharmaceutical industry building quality systems in support of drug development, commercialization, and GxP quality and compliance. She has experience with oversight... Read More →
avatar for Maryrose Petrizzo

Maryrose Petrizzo

President and Principal Consultant, Clinical Quality Assured, LLC
Maryrose has over 20years of GCP experience in Clinical Quality Assurance and Quality Systems for the pharmaceutical, biologics and medical device industries including: site and process auditing, inspection readiness, due diligence, acquisition integrations, and clinical vendor management... Read More →

Wednesday June 27, 2018 12:00pm - 1:00pm EDT
E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  15: Engage-Exchange, Workshop