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Computer System Validation and Part 11 Compliance

 
  December 10, 2019  
     
 
CfPA-The Center for Professional Advancement, Online Live
February 5, 2020 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
This course is intended for professionals from the Pharmaceutical, Biologics, Medical Device and related industries who work in the following areas:
  • Quality Assurance/Quality Control
  • Project Management
  • Information Technology
  • System Validation
  • Engineering
  • Manufacturing

Anyone from the above departments that enters data in a computer system, that pulls reports from a computer system, that operates equipment that stores data, engineers, QA and QC analysts, equipment operators, maintenance personnel will find this course beneficial.

Course Description
Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. This 90 minute accredited training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.

Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, this course will enable regulated companies to ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Joy McElroy, Consultant to the Pharmaceutical and Biotech Industries

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.

In 2013 Joy started, Maynard Consulting Company, which provided engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States.

In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off site training to pharmaceutical and biotech companies throughout the United States, Canada, and the world.

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.
 
Deadline for Abstracts: N/A
 
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
 
 
   
 
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