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. In 2013 Joy 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.
What is adulteration?
- Pharmaceuticals
- Biologics
- Medical Devices
What is CGMP?
- Pharmaceuticals
- Biologics
- Medical Devices
What is GLP?
- Contract Laboratories
- FDA inspection methodology
Laboratory Organization
- Organization
- Personnel qualification and training
Documentation and record-keeping requirements
- Standard Operating Procedures
- Analytical Methods
- Raw data (notebooks, print-outs)
- Document management (change control, retention)
- Part 11 (electronic records and signatures)
Sample integrity requirements
- Sample collection
- Sample delivery, handling, disposition
- Retain samples
Stability (shelf-life) studies
- Organization and management
- Storage units
- Analytical methodology
Analytical methods verification and validation
- Protocols
- Tests
- Documentation
Management and control of laboratory instruments
- Qualification
- Calibration
- Maintenance
Management and control of laboratory supplies
- Standards
- Reagents, chemicals
Proper conduct of laboratory investigations
- Out-of-specification results
- Out-of-norm results
- Root cause analysis
- Documentation
Consequences of Laboratory non-compliance
Interactive Discussions and Q&A Session