Quality Control Laboratory Compliance – cGMPs and GLPs – 6 Hours Virtual Seminar

Good Laboratory Practices (GLPs), 21 CFR part 58 is a set of guidelines 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 not enforceable by law. They do not include manufacturing of product. GLPS are 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.

GMPs, Good Manufacturing Practices, 21 CFR part 210 and 211, is a set of guidelines for the actual manufacturing and packaging of finished products. The GMPs are enforceable by law. During this course GLPs and GMPs will be compared and contrasted. The differences and similarities will be discussed. The attendees will gain a better understanding of how these guidelines work together and enable the finial production of quality products.

Course Objective:

• During this webinar participants will learn what GLPs and GMP are, how they are similar and how they are different. They will learn how and why both these regulations were created, a brief history of each will be given.
• Participants will have a better understanding of the importance of these regulations and how they work together to enable production of the highest quality products.
• Participants will also gain an understanding of the consequences of noncompliance such as disqualification and reinstatement.

Seminar Agenda:

Session 1:

^{Understanding FDA law and regulations for QC laboratories}

• 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

Session 2:

^{Documentation}

• 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

Session 3:

Management and Control

• 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
  • Root cause analysis
  • Documentation
    

• Proper conduct of laboratory investigations

Who Should Attend:

Senior directors, managers, supervisors and those who have responsibility for ensuring that QC laboratory operations and practices comply with current good manufacturing practices and good laboratory practices.

• 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

Course Director: 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.