NATOLI HAS PARTNERED WITH FDA COMPLIANCE EXPERT TO OFFER BRAND NEW TECHNICAL TRAINING COURSE
FDA Solid Dose GMP and Compliance
SEPTEMBER 3, 2009 - Natoli Engineering Company, Inc. has partnered with FDA compliance expert, Mary L. Richardson, to offer a brand-new technical training course, FDA Solid Dose GMP and Compliance. The three-day course was designed to introduce and explain in detail the complexities of complying with new FDA Enforcement Policies announced in August 2009, and how to respond to 483 observations. The new course will take place on October 27-29, 2009 at Natoliís technical training center in St. Charles, MO. Attendees of this course will gain a more complete understanding of what the FDA expects from you and your company in order to comply with the cGMPs and all other related guidelines.
The course guest speaker, Mary L. Richardson, is currently a private consultant with over 35 years of experience in the food and drug industry and as Deputy of the Division of Scientific Investigations at the FDA. Her invaluable experience enables her to enlighten attendees with first-hand perspective on cGMP regulations, how to prepare for a FDA pre-approval inspection, and how to respond to FDA 483 observations. ďThis course is for those who seek knowledge and understanding of what FDA expects your firm to do to maintain compliance. It's easier to stay compliant, rather than return to a compliant status once FDA has inspected and determined that your manufacturing is out of cGMP control.Ē ĖMary L. Richardson
Natoliís technical training center is the most influential, non-commercial training center in the United States that is solely dedicated to the pharmaceutical solid dose industry. The centerís curriculum is structured around hands-on training, theories, case studies, processes, and techniques of tablet compression. The 2010 technical training course lineup is currently being assembled, and will be available in the near future.
Editorís Note: For additional information about Natoliís 2009 Technical Training Courses, visit our website at http://www.natoli.com/Training/Technical-Training.aspx.