GLP Training
Instructor
Dr. Bill Spanogle | Biotech Research Group
Bio:
Bill is a highly accomplished, adaptable C-Level Advisor and hands-on leader in the full spectrum of Regulated Life Sciences Product & Process Development, RA/QA, EU-MDR/IVDR, QbD, and CSV-GAMP-Part11. Bill has successfully characterized and taken scores of medical devices, Biotech, Pharma, and Combo Products, Designs, Materials, & Processes from concept through commercialization via QbD, Design Controls, Risk, PMS, CER, PRRC, data trending, submissions, site inspections, turnarounds, and all intermediate functions. He is a recognized international & domestic invitational Biotech, medical device, Combo, CSV, and regulated life science leader, presenter, assessor, remediator, instructor, implementor, and author. Those who have and do work with Bill, continually nickname him “Doctor Bill” for his passion, skills, integrity, and compassion in effectively aligning and harmonizing people and organizations within the regulated life science Industry. Bill’s Regulated Life Sciences background includes, but not limited to, Management, Leadership, and Director Levels for J&J Medical Devices, Biotech, Stem Cells, IVDs; turnaround of Carefusion, and IVD Submissions Serono-Baker, respectively. These experiences span several decades, multiple continents, numerous International Regulatory Bodies. His Medical Device Design Control expertise has its roots in his nearly five years of Software Design and Development and Controls. To-date Bill has led and guided >4000 professionals, across multiple global Sites, in Design Controls, CSV, Part 11 GAMP & QbD, and 1000s of professionals as an Invitational Presenter at numerous Professional Conferences, and 1000s more via publications and ISPE Guide Series.
Certificate
All participants who successfully complete the course will receive a Certificate of Completion in “Current Good Laboratory Practices,” a valuable and required credential for employers and regulatory agencies.
Objective
During this Live Online Training Course, a subject matter expert will share their expert knowledge about important aspects of current Good Laboratory Practices. In this course you will learn the most important aspects of GLP, get a basic overview of GLP requirements and become familiar with technical terms from the field of GLP and their meaning. An overview of regulatory inspections will be covered.
Background
Current Good Laboratory Practices (cGLP) are guidelines for conducting nonclinical laboratory studies that support or intended to support applications for research or marketing permits for regulated products. During this training, you will learn how they shape the everyday procedures that oversee any given company’s work in this field. Participants will develop a great understating of GLP, including its principles, history, and significance in laboratory research.
This Live Online Training Course has been designed by AAQF to provide useful information which is needed for an efficient management of regulated products.
Target Group
- Anyone involved in nonclinical studies
- Managers and executives
- Laboratory Technicians
- Scientists
- Researchers
- Toxicologists
- Students interested in Laboratory Science
- Regulatory Affairs Staff
- Quality Control/Quality Assurance Staff
Technical Requirements
AAQF uses Zoom for our live online training courses and webinars. After successful registration, you will receive a link with all the Information you need to participate in AAQF trainings, and you can check if your system meets the necessary requirements to participate. Zoom can be accessed by their application or by any browser (Google Chrome works best). Zoom is a standard method for training and is fast and easy to access.
Program
Day 1
Session 1 (0900-1200)
- History of GLP
- Global Regulatory Agencies: FDA, EPA, & OECD
- Personnel
- Training
- Facility
- Equipment
- Chemicals, Test Articles, and Solutions
- Questions & Answers
Break (1200-1215)
Session 2 (1215-1515)
- Use of Animals in Research and Testing
- Animal Welfare Act
- Vivarium Operations
- Collection of Specimens
- Euthanasia
- Necropsy
- Protocol Compliance
- Raw Data Collection & Analysis
- Data Integrity & Management
- Questions & Answers
Day 2
Session 1 (0900-1200)
- Laboratory Safety Protocols
- Quality Assurance
- Quality Management System
- Standard Operating Procedures
- Deviations
- CAPA
- Change Control
- Questions & Answers
Break (1200-1215)
Session 2 (1215-1515)
- Hazardous Waste Management
- Final Report of Study Results
- Archiving Study Data
- Archiving Specimens
- Audits and Self-Inspections
- FDA Inspections
- Animal and Plant Health Inspection Service (APHIS)
- Questions & Answers