Robert has presented many GMP training courses during his tenure at FDA and while working as a consultant, some of which are described as follows: 

• Between 2017-2019 Robert prepared and conducted GMP training courses in both solid oral and liquid manufacturing dosage. As VP of Compliance, Robert mentored QA and production personnel in GMP requirements and provided re-training when needed.   
• In 2015, at a foreign sterile filling site, Robert assisted another consultant in providing both classroom and on-floor GMP training to (12) newly hired QA inspectors.  We used “GMP in Practice; Regulatory Expectations for The Pharmaceutical Industry”, James L. Vesper, 4th edit, as the training manual and provided a copy to each attendee.  This training was formally structured and required attendees to make classroom presentations regarding assigned chapters and required passing written exams prior to completing the program.
• In 2009 Robert trained new employees in deviation investigations and preparing deviation reports at a large sterile, aseptically filled facility. Robert served as the team lead for a group of 5-6 individuals responsible for investigating “operator error” deviations where he coached the deviation writers and edited the deviations in Trackwise as a Functional Reviewer. In addition to providing supervisory oversight, he provided on-floor investigation training and assisted with identifying root cause analysis and assisted with drafting effective CAPAs to prevent the reoccurrence of similar deviations. 

• In 2006, Robert provided on-floor QA oversight at a solid oral, sustained release dosage manufacturing operation to assure operators adhered to established practices and following the batch production records, room and equipment cleaning procedures.

While at FDA, Robert served as a trainer on many investigator training courses at the national, regional and district levels. While serving as a supervisory investigator, Robert developed a drug training program, similar to the national basic drug training course that was presented to his group of newly hired investigators.  

Robert worked with another Mid-Atlantic Regional Drug Investigator and prepared a training manual entitled “Solid Oral Dosage Manufacturing & BPR Issues” that was focused on capturing the important inspectional areas of concern when conducting a drug inspection.  The training material and manual was provided to the new hires.  The training included a 2-day training course at a local pharmaceutical facility which is summarized under the heading “Non-Sterile Manufacturing” drop-down menu.