GLPs: How are they Associated with GMPs and SOPs
In this Session you will learn the objective of GLPs and how are they associated with GMPs and SOPs , and also what Good Laboratory Practices are and to understand and compare the differences with GMPs, Good Manufacturing Practices.
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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:
Who Will Benefit:
- 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
- Quality Assurance Personnel
- Quality Control Personnel
- Research and Development Personnel
- Regulatory Affairs Personnel
- Project Managers
- Manufacturing Managers
- Validation Engineers
- Internal Auditing Personnel
- Microbiology Personnel
Joy McElroy 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, 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 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.
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.