Join us for an interactive, hands-on training designed to provide you with practical tips to help improve efficiency in your master manufacturing record (MMR) and batch production record (BPR) processes. This course is part of maintaining required compliance to 21 CFR 111 and provides opportunities for ongoing GMP training.
Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, participants in this course will:
At the end of the course, you will know and understand:
Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.
Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.