While working at FDA Robert served as a Supervisory Drug Investigator and the PAI (Pre-Approval Inspection) Manager, where he was responsible for scheduling Pre-Approval Inspections, reviewing PAI reports and where necessary, recommending proposed regulatory actions. 

Robert served as one of FDAs National Drug Experts and earlier as one of the Mid-Atlantic Regional Drug Specialist where he conducted both domestic and international PAI’s as well as routine general GMP inspections.

After retiring from FDA in 2004, Robert developed an effective PAI readiness approach that has been used in securing many successful PAI’s, several of which resulted in no FD-483 being issued. The PAI readiness approach identifies critical processes, systems, and associated deviations for assigned SME’s (subject matter experts) who are then coached to better prepare them for possible inspection interviews.  Robert also developed detailed coaching questions for each major system to better assist with preparing the SME coaching efforts.

In addition to using his PAI readiness approach to help coach the SME’s, Robert electronically tracks “inspection readiness activities” for critical processing and quality related systems to identify GAPs that often requires increased attention. His approach also includes identifying objectionable conditions cited at any related and/or sister sites to make sure that any previously cited non-compliant activities were properly addressed.  

Some of Robert’s successful PAI’s include:

• a sustained-release sterile microsphere injectable product 
• a foreign sterile bulk antibiotics and vial filling process at a new facility expansion
• three RABS (restricted assess barrier systems), two of which were syringe filling lines, and one vial filling line
• a non-sterile fermentation filling manufacturing process
• an isolator, located inside a BSL-2 suite, used for vial filling and/or lyophilized products
• a non-sterile NDA tablet operation, two ANDA tablet operations and an NDA liquid dosage process.

Robert maintains an active membership in the PDA & ISPE to help remain current with new and/or revised guidance documents.