The objective of this webinar is to compare and contrast between Good Laboratory Practices
and Good Manufacturing practices.
Why you should attendGood Laboratory Practices (GLPs)
21 CFR part 58 are not set of guidelines but they are regulations for
conducting nonclinical laboratory studies that support or are intended
to support applications for research or marketing permits for products
such as food and color additives, human and animal drugs, medical
devices for human use, biological products and electronic products that
are regulated by the FDA.GLPs
are enforceable by law. They do not include manufacturing of product. GLPS
for non-clinical laboratory studies in which tests article are studied
in test system under laboratory conditions to determine their safety.
This does not include studies utilizing human subjects, or clinical
studies, or field trials on animals.
- 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
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.
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.
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
Time: 08:00 AM PDT | 11:00 AM EDT
- GLP: Good Laboratory Practice
- GLP is an FDA Regulation
- Definition of GLPs
- History of GLPs
- Why was GLP Created?
- Objectives of GLP
- Mission of GLP
- Instrumentation Validation
- Analyst Certification
- Laboratory Certification
- Grounds for Disqualification
- Consequences of Noncompliance
- Reinstatement of a Disqualified Facility
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