Compliance Officer Regulatory

Robert Sharpnack, President

Sharpnack Consulting Service, LLC

P.O. Box 11415

Cincinnati, Ohio 45211

Mobile: 513-***-****

Email : ************@*****.***

Alternate: ************@*****.**.***

Objectives

To use acquired industry and FDA knowledge and skills to:

oAssist pharmaceutical, vaccine and active pharmaceutical ingredient (API) manufacturers with their commissioning, qualification and validation activities of processes and critical systems;

oDevelop and successfully implemented a PAI (pre-approval inspection) readiness program;

oProvide regulatory compliance oversight in responding to FD-483 items;

oProvide on-floor quality oversight (MQA) at aseptic and solid-oral dosage manufacturers;

oAssist with deviation investigations, change controls and CAPA management.

Quality/Regulatory Consulting (Aug 2004 to Present)

oHas a sound knowledge and understanding of quality systems, production control procedures and associated systems as well as laboratory operating practices and procedures to help clients maintain a sustained cGMP compliance status.

oIn 2013 assisted a sterile manufacturer in getting their FDA warning letter removed.

oServed as a quality consultant assisting domestic and international clients prepare for and successfully passing many routine and/or PAI’s.

oAssisted in designing, building, and qualifying a BSL-2 isolator filling suite and a controlled Hormone manufacturing suite.

oSterile filling knowledge includes traditional aseptic filling, restricted access barrier systems (RABS) and isolators. Many of the PAIs resulted in no FD-483 items being issued.

oAssisted several sterile manufacturers with improving personnel and material flows, improving process simulations and providing quality oversight for media simulation and commercial production runs.

oProvided classroom and on-floor aseptic training to newly hired MQA personnel.

oConducted third party, due diligence and simulated mock FDA readiness inspections.

oProvided compliance remediation assistance in responding to and developing successful corrective action plans in response to FDA cited deficiencies at pharmaceutical manufacturers and contract testing laboratories, two of which involved data integrity issues that were also successfully remediated.

oSupervised individuals responsible for investigating, and developing corrective and preventive actions to non-conformances/deviations at both sterile and sold-oral dosage manufacturers with an assignment as a functional manager in Trackwise.

oDeveloped and presented training courses on deviation investigation and root cause analysis and basic GMPs for new employees.

oFrom 2005/2006 served as a Senior Compliance Advisor in the Corporate Quality Group at a full-service Clinical Research Organization (CRO) providing regulatory guidance, hosting sponsor audits and performing both internal and external clinical audits.

oProficient with Microsoft Office, Trackwise deviation system, Documentum and IsoTrain electronic data systems

Consulting Work History

The following is a summary of my consulting work history from Sep 2004 to present:

Feb 2022 to May 2024: Served as the VP of Quality at ECI Pharmaceuticals assisting the production and quality departments in daily operations in producing non-sterile solid oral and liquid dosage manufactured products. In April 2022 facilitated a week-long FDA GMP inspection that resulted in no FD-483 items being issued.

Aug 2020 to Dec 2021: Served as an aseptic processing SME with (4) other consultants in providing on-floor production oversight with the aseptic filling of an Inova Optima syringe filling line, a RABS Bausch & Strobel vial/lyophilization filling line and an Optima Isolator filling line. Reviewed smoke studies and identified aseptic interventions that required additional smoke studies. Provided formal training to all operators with regards to proper aseptic technique and the importance of properly prepping and wrapping autoclavable parts. Our consulting team provided on-floor oversight with staffing on all 3 production shifts. We also assisted with writing/editing deviations, CAPAs and change controls.

Jan 2017 to Jul 2020: V.P. of Compliance at a solid oral dosage and liquid manufacturer in south Florida. Duties include provide regulatory compliance oversight to the manufacturing activities to assure regulatory Agency expectations are met while meeting product demands. Oversee the review and where necessary revisions to all quality system procedures and assist the quality group with day to day activities. Initiated my PAI readiness program to prepare the solid oral dosage and separate liquid company for upcoming pre-approval inspections.

In Aug 2017 both sites received receive FDA site approval for (2) PAIs in the solid dosage building and (1) PAI for an NDA in the liquid company without receiving any FD-483 items. Served as the facilitator and assisted with identifying, designing and drafting the necessary operational procedures needed to successful operate a segregated hormone manufacturing suite in the non-hormone solid oral dosage building.

In Feb 2019 repeated the facilitator role in assisting with hosting a general cGMP FDA inspection of the solid oral dosage company and again, did not receive any FD-483 items. Assisted production with designing the personnel, material and equipment flow in a newly dedicated and segregated hormone manufacturing suite. Facility qualification confirmed with EM swab samples from the outside floor the lack of any hormone residue.

Sep 2015 to Dec 2016: Worked with the quality validation department at a large vaccine manufacturing site in PA by assisting with reviewing commissioning and qualification activities for a new isolator filling line, contained within a BSL-2 boundary. Duties include assisting with personnel and material flows, qualification and validation review activities for the building VHP process, validation of the isolator filling line and associated systems/clean utilities. Also assisted regulatory affairs on developing proposed agenda topic for a CBER type C meeting and assisting the site with subject matter expert (SME) coaching during regulatory inspections. In Dec 2018 the isolator fill line received both FDA and Health Canada regulatory approval.

Oct 2014 to Aug 2015: Worked on remediating a Warning Letter at a large vaccine manufacturing site in Canada. Primary duties include assisting the validation work stream in reviewing site validation protocol and reports and laboratory test methods and coaching validation SMEs. Suggested revising the VMP procedure to provide a monthly summary of validation activities completed, validation activities added and validation activities either removed or rescheduled. The recommended electronic database would provide generating faster monthly queries as to validation accomplishments. Duties also include red-lining validation protocol and report templates to incorporate elements of appropriate PDA technical reports in the templates; served as an SME coach during a Health Canada inspection in Feb, 2015 and a successful FDA PAI inspection in Jul 2015. Provided several inspection readiness training sessions and performed mock FDA inspections to identify possible gaps where improvements can be made to better prepare the site for upcoming regulatory inspections.

Jul 2014 to Oct 2014: Served as one of the aseptic filling SMEs at a large sterile drug manufacture in northern Italy where we provided 24/7 on-floor QA responsibilities, coaching operators and newly hired MQs in GMPs and proper clean room behavior. Passed Grade A gown training with daily responsibilities included completing QA checklists covering component weighing, solution preparation and ampule filling activities. Duties also included daily inspecting/releasing Grade A filling cleanroom. We also designed and provided formal cGMP training to (13) newly hired QA individuals that were hired to assume on-floor QA responsibilities. All training was successfully executed.

Jan 2014 to Jun 2014: Served as the aseptic SME at a large sterile medical device manufacturer in Turkey of custom tubing sets, cardioplegia sets, pressure lines, various catheters and cannulas to assist with providing on-floor QA oversight and assist with developing effective non-conformance and CAPA procedures to correct reoccurring deviations. Also, assisted in drafting FD-483 status updates and provide general compliance guidance.

Nov 2011 to Dec 2013: Served as the aseptic processing SME at a large sterile manufacturing site in NC. Duties included working with small workgroups to improve personnel and material flows, instituted a new dedicated gowning practice, making process simulations (media fills) more robust, improve smoke studies for better laminar airflow profiles, proving on-floor MQA oversight and assisted sister sites host FDA inspections by coaching the SMEs. The company received a successful subsequent FDA inspection.

Jun 2007 – Oct 2012: Served as a member of the quality group at a large vaccine manufacturing site in PA. Duties included; assisted quality in providing oversight of the commissioning and qualification activities of the process and critical systems to include CIP/SIP, autoclaves, depyrogenation tunnel, clean utilities and process validation for a new flu filling building (two syringe and one vial filling lines), developed personnel and material flows, assisted with the environmental monitoring performance qualification (EMPQ), coached operators during water simulation runs and media fills and subsequently coached the SMEs during CBERs PAI visits.

oValidation documentation reviewed included; Girton parts washer, Ultrasonic rinse console, Inova vial washer, INOVA depyrogentation tunnel, Bosch syringe debagger, denester, INOVA Syringe Filler, re-nester, Seidenader automated inspection machine and Getinge autoclaves. All PAI inspections were very successful. Also assisted another building in a bulk flu manufacturing PAI readiness activity, and then finally assisted with an isolator filling operation that also received PAI approval.

oPart of this assignment was to also assist preparing their Rockville, MD site for an FDA PAI inspection. Work included similar activities performed at Swiftwater, PA and resulted in an approved PAI.

Jan 2006 – Dec 2006: Served as a member of the quality group to help remediate FD-483 deficiencies a large sustained-release dosage manufacture in south FL. Duties included; assisting in drafting process validation protocols, on-floor MQA and coaching deviation investigation team. Also, assisted regulatory affairs in drafting an FD-483 response and accompanied company management to present our corrective actions to FDA/CDER, located in Rockville, MD. Subsequent FDA inspection only identified minor objectionable conditions.

Sep 2004 – Dec 2006: Worked as an employee of AAC Consulting Group and assisted a sustained-release sterile microsphere manufacturer secure CDER PAI approval. Also worked at Kendle International, AAC’s parent facility, a full-service CRO (clinical research organization).

Food and Drug Administration (Aug 1972 – Aug 2004)

Over 30 years of FDA experience where inspectional activities focused primarily on inspecting pharmaceutical establishments for adherence to FDA regulations. Work included; sterile & non-sterile finished dosage, APIs, manufacturing of clinical trial materials with associated manufacturing and processing systems. Also routinely inspected clinical investigators, sponsor-monitors, Institutional Review Boards and non-clinical (animal) research facilities.

National Drug Expert (Sterile Pharmaceuticals)

Mid-Atlantic Regional Drug Investigator and conducted pharmaceutical inspections within the region as well as served as a trainer at FDA national, regional and district training courses.

Member of FDA’s foreign inspection cadre (1985-2004) conducting for-cause and pre-approval inspections.

District Compliance Officer responsible for reviewing inspection reports and preparing regulatory action recommendations.

Supervisory Investigator responsible for the development and work activity of the drug and bioresearch inspection group.

FDA field reviewer on the ISPE Baseline Guide for Commissioning & Qualification.

FORMAL EDUCATION

1991-1992: University of Cincinnati, College of Pharmacy.

Industrial Pharmacy I and II post-graduate studies which focused on process development and scale-up, validation issues for API, solid oral dosage and sterile pharmaceuticals.

1989-1990: Cincinnati State College. Computer Science training.

1972-1980: University of Cincinnati, B.S. Natural Sciences; Major, Chemistry; Minor, Administrative Management.

PRESENTATIONS/PUBLICATIONS

While serving as one of FDA’s Regional Drug Specialists, frequently presented drug-related topics at national, regional and district level training courses for FDA investigators and analysts. Also was regular lecturer to the University of Cincinnati, College of Pharmacy, Industrial Pharmacy Graduate Program. A detailed list of presentations available upon request.

While serving as a Regional Drug Investigator with FDA, I was one of the Agency reviewers on the ISPE – Baseline Guide for Commissioning & Qualification. This Baseline Guideline was recently updated with version 2.

PROFESSIONAL AFFILIATIONS

2013 - Present: Member, Parenteral Drug Association (PDA)

1992 - Present: Member, American Society for Quality (ASQ)

Awarded senior status in March 2003

2004 - Present: Member, Regulatory Affairs Profession Society (RAPS)

2017 – Present: Member, ISPE (Institute of Society of Pharmaceutical Engineers)

CERTIFICATIONS/TRAINING

Dec. 96 - Present: ASQ, Certified Quality Auditor (CQA)

Jun 6, 2014: BPI (Business Processes Inc.) Critical Thinking Training focusing on Investigations, Root Cause Analysis and Critical Thinking

AWARDS/RECOGNITION

August, 2004: During Robert’s FDA retirement luncheon, the Dean of the University of Cincinnati, College of Pharmacy presented Robert with a plaque recognizing his contributions over the previous 10 years to the Industrial Pharmacy Program by providing regulatory compliance training to graduate and Ph.D. candidates. He performed this work on his own personal time.

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