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The Annual Meeting program is subject to change. Speakers are added as confirmations are received.
Please  note that Quality College workshops require separate registration.

Please review the Safety Rules and Guidelines.
Thursday, April 12 • 1:30pm - 5:30pm
Workshop 16 - General 104: Three Cs of SOPs: Clear, Concise, and Compliant in a Regulatory Setting (1/2 day)

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RQAP re-registration units: 1 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course will cover the full life-cycle of controlled process documents - from creation through archival. Topics will also include responsibilities, training, and non-compliance. Attendees should be prepared to bring examples of questions relating to SOPs (controlled process documents) and SOP management.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the purpose and benefit of effective SOPs
  • Understand the critical role of SOPs in Quality Documentation systems
  • How to write a concise, unambiguous SOP for its intended purpose
  • Define clear responsibilities to promote action and closure within the document
  • Training requirements
  • Manage revisions, nonconformance and deviations from a current SOP
  • Difference between GCP/GLP/GMP

Target Audience
Anyone who is responsible for life cycle and compliance of these key components of the Quality Management System. This course is applicable to all; GMP, GCP, GLP, and GVP. This course is applicable for beginners as well as experienced personnel.

Agenda
  • Understand the purpose and benefit of effective SOPs
  • Understand the critical role of SOPs in Quality Documentation systems
  • How to write a concise, unambiguous SOP for its intended purpose
  • Define clear responsibilities to promote action and closure within the document
  • Training requirements
  • Manage revisions, nonconformance and deviations from a current SOP
  • Difference between GCP/GLP/GMP
Class will include team exercises

Speakers
avatar for Joe Franchetti

Joe Franchetti

Managing Consultant, JAF Consulting, Inc.
As JAF Consulting Incorporated’s Managing Consultant, Joe Franchetti is an industry leader and teacher for Data Integrity, 21 CFR Part 11, Annex 11, and Computer System Validation in regulated environments. For over twenty-five years, Joe has been involved with the development... Read More →
avatar for Barbara Munch

Barbara Munch

GlaxoSmithKline
Barb Munch, BS, is Director, R&D Pharma GLP Risk Coordinator in global toxicology, within GlaxoSmithKline (PA, UK). This group conducts GLP in-vivo and in-vitro toxicology studies for pharmaceutical test articles. Her 39-year career has been in the nonclinical regulatory environment... Read More →
avatar for Michelle Thompson

Michelle Thompson

Vice President, FDA Quality and Regulatory Consultants, LLC (FDAQRC)
Mrs. (Holbrook) Thompson has been working in quality assurance for over 15 years and joined FDA Quality and Regulatory Consulting (FDAQRC) in 2015. She completed her Bachelors of Science at North Carolina State University. Mrs. Thompson has been a Registered Quality Assurance Professional... Read More →
avatar for Judy Zahora

Judy Zahora

Head, Project Management Office, Biogen
Ms. Zahora is Global Lead, Process Documentation Management for R&D at Biogen where she defines and implements R&D GxP documentation standards to ensure compliant, clear, and effective documentation of GxP processes. She has over 30 years’ experience working in IT, Finance, Process... Read More →


Thursday April 12, 2018 1:30pm - 5:30pm
Platinum 9&10

Attendees (17)