Upon completing this course participants will understand:
1. Opening meeting
2. Touring the facility
5. Close out meeting
1. ASQ Certification
2. ISO Certification
The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.
This 90 minute overview is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance specifically related to equipment, processes and documentation. The following personnel will benefit from the course:
Attend this webinar to learn in depth about:
Upon earning a degree in Zoology at North Carolina State University, I began working in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing. My work allowed me to move into a supervisory role at Abbott Laboratories where I oversaw the Quality Control Lab. In 1998 I moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, holding annual GMP training for new employees, and writing audit report, and SOPs. After working in Quality Assurance for a few years, I moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
With 12 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, I have gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, and Technical writing. I have written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. I also develop and deliver webinars, on-site training, and seminars for training in areas such as Technical Writing, Equipment Qualification, Cleaning Validations, FDA Audit Preparation and more.
In 2013 I started my 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.