Robert has considerable regulatory and consulting experience in sterile manufacturing, especially aseptic filling. Robert’s consulting work includes bulk manufacturing and fermentation operations, a sustained-release sterile microsphere manufacturing process, aseptic filling in both traditional filling suites as well as in RABS (restricted access barrier systems), and multiple isolator filling lines including product lyophilization.  Robert also assisted in the design, installation and qualification of a BSL-2 manufacturing suite.  

Robert has reviewed and edited  process validation protocols for manufacturing equipment and systems utilized in manufacturing sterile pharmaceuticals. Robert assisted in designing efficient personnel and material traffic flows for controlled processing areas to help reduce the ingress of microbial contamination, helped draft multiple environmental monitoring performance qualification protocols (EMPQs) and improved aseptic process simulations (media simulations) protocols at multiple sites.  

Robert participated in providing on-floor QA coverage during media simulation runs at a large vaccine filling operation to successfully support and gain FDA approval for a 24-hour aseptic filling operation.  Robert also assisted in providing oversight during consistency (stability) batches and all clients received FDA approval. 

At a large vaccine site, Robert assisted the quality validation (QV) group by providing on-floor oversight and review of validation documentation for a new yellow fever vaccine isolator filling line, contained within a BSL-2 suite.  Duties included reviewing and red lining a proposed building vapor hydrogen peroxide (VHP) protocol that when executed, showed adequate decontamination of the facility prior to changing to another sterile product campaign.  Robert reviewed and red-lined commissioning and qualification (C&Q) documentation for the vial washer, depyrogentation tunnel, filler, lyophilizer and capper.  This filling line received approval by FDA and the Canadian Health Authority in December 2018. 

While at FDA, Robert participated as an Agency reviewer of the ISPE Baseline Guide for Commissioning and Qualification in which the current version continues to be used by industry for qualifying new and/or renovating manufacturing facilities.  

Robert is very knowledgeable of the FDA, EU, TGA and MHRA regulations and expectations for producing sterile pharmaceuticals and vaccines. He is also knowledgeable of ICH and the PDA technical reports, which are used by industry and regulatory inspectors.