This Computer System Validation Training will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. 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.
Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, regulated companies must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters.
Upon completing this course participants should:
This CSV webinar will benefit all who use computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.
Years of Experience: 20+ years
Areas of Expertise: Quality Assurance, GMP Compliance Audits, and Equipment Qualification
Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. McElroy 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, she moved into equipment qualification and cleaning validation at Mallinckrodt.
With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.View all trainings by this speaker