Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Joy McElroy
OVERVIEW:
In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.
Why should you Attend: To learn what Good Laboratory Practices are and to understand and compare the differences with GMPs, Good Manufacturing Practices.
Areas Covered in the Session:
– What are Good Laboratory Practices
– Why were they created
– What is the objective of GLPs and how are they associated with GMPs and SOPs
– Statistical Procedures for data Evaluation
– Instrumentation Validation
– Analytical and laboratory Certification
– Documentation and Maintenance of Records
– Consequences of Noncompliance
– Disqualification and Reinstatement
Who Will Benefit:
– Quality Assurance Personnel
– Quality Control Personnel
– Research and Development Personnel
– Regulatory Affairs Personnel
– Project Managers
– Manufacturing Managers
– Validation Engineers
– Internal Auditing Personnel
– Microbiology Personnel
– Auditors
SPEAKER PROFILE:
Joy McElroy Upon earning a degree in Zoology at North Carolina State University, Joy 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 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 over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.
Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.
