Mark L. Balboni BALBONI CONSULTING GROUP LLC 2813 E 3600 N Layton, Utah USA mobile: +1 (801)

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1 Mark L. Balboni BALBONI CONSULTING GROUP LLC 2813 E 3600 N Layton, Utah USA mobile: +1 (801) balboniconsultinggroup@gmail.com Summary of Experience Mark Balboni is the Principal & General Manager of Balboni Consulting Group LLC, which was founded in He is a former Senior Director GMP Compliance at BioMarin Pharmaceutical, former Director at PAREXEL Consulting, and former Investigator with the U.S. Food and Drug Administration (FDA) in Los Angeles, California. Mr. Balboni s 27 years of current Good Manufacturing Practice / Quality Systems Regulations experience spans the pharmaceutical, biologics and medical device industries. He is an expert in the areas of GMP auditing for sterile and non-sterile finished products/devices, APIs and testing labs; performing data integrity investigations; evaluating validation & qualification study data; applicability of GMPs in an R&D environment; conducting deviation investigations and CAPA implementation; and preparing for regulatory inspections. While at FDA, Mr. Balboni was a drug investigator and a member of the Pacific Region Pre-Approval Inspection cadre. In addition to performing GMP and Pre-Approval inspections, he also worked with Federal and State law enforcement officers over several years in conjunction with a large number of criminal investigations involving anabolic steroids, illegal importation of Chinese patent medicines, Prescription Drug Marketing Act violations and health fraud. Mr. Balboni also attended a 12-week criminal investigator training program held at the Federal Law Enforcement Training Center (FLETC) in Glynco, Georgia. Mr. Balboni is also a military veteran and former commissioned officer in the U.S. Army Reserve, where he received an honorable discharge after serving as a Captain in the Medical Service Corps. Mr. Balboni received a Bachelor of Integrated Studies (BS) Degree from Weber State University, with an emphasis in Zoology, Chemistry and Physical Education Present Principal & General Manager Balboni Consulting Group, LLC Layton, Utah Owner and founder of a GMP and Quality Systems consulting firm providing timely services to clients in the pharmaceutical, biotechnology and medical device industries, both the US and internationally. The portfolio of GMP consulting services, includes but is not limited to: GMP Auditing: sterile and non-sterile finished products/devices, APIs, testing labs, warehouses (GDP)

2 Strategic Advisement: health care authority communications/meetings, remediation and verification Inspection Support: hosting, front/back room support, mock interviews, etiquette training, readiness assessments, Application conformance reviews Data Integrity: training, procedure development, auditing, interviews of staff, internal investigations, coordinate efforts with legal counsel Deviation Investigations & CAPA: problem identification and resolution, report writing Project Management: compliance remediation efforts, organizational/systems redesigns Senior Director GMP Compliance BioMarin Pharmaceutical Inc. San Rafael, California Lead an internal/external GMP and Computer Validation audit staff of 9 Successfully managed a department budget of $3M Provide strategic advisement to executive staff on GMP compliance matters and acted as an internal SME Designed/redesign and built key systems to support the audit functions in a growing company. Ensured a high state of readiness for health care authority inspections and partner audits President Mark Balboni, LLC Layton, Utah Owner and Expert GMP and Quality Systems Consultant skilled to provide timely solutions to clients in the pharmaceutical, biotechnology and medical device industries. A former FDA Investigator who has also worked in the pharmaceutical and biotech industries as a regulatory compliance professional. Example of services: Auditing: GMP, Quality Systems, Management Controls, FDA-type Mock PAIs and Inspections, Verification Audits and Effectiveness Checks, Gap Analyses Regulatory Compliance: 483/Warning Letter responses and other correspondence, Consent Decree remediation activities, preparation for or attendance at FDA meetings Training: General GMP topics, FDA interaction and preparing for FDA inspections, 1:1 mock interviews, auditing techniques Inspection Management Process and Planning: Review hosting process and site presentations, tour routes, front/back room management, document management, employee coaching Data Integrity: Directed audits and analysis, company program development, subject matter training Technical Writing: Validation Protocols and Reports, SOPs, Annual Product Reviews, FDA correspondence, audit responses, strategic plans, trend analysis reports, other technical reports. Data Trend Analysis: Collection, review, analysis and summary reporting for Deviations, OOS, Change Controls, CAPA, Complaints, Product Returns

3 Director PAREXEL International Layton, Utah Key Accomplishments: A member of the consulting practice leadership team, and also managed a staff of 6 consultants. Was a project manager on approximately 20 different client assignments, with anywhere from 4-12 consultants, and spanning from 3 weeks to 8 months in duration. Successful negotiation of new client business, with total sales in the tens of millions of dollars; to include preparing scopes of work, price estimates and defending bids. Served in a loan executive capacity for one client, in support of the site Quality Assurance Department at a large chemical manufacturing site for 3 months. Worked full-time for 8 months at a sterile biologics manufacturer writing media fill protocols, reviewing and revising SOPs, performing facility reviews, evaluating validation studies for: media fills, sterile bulk hold studies, cleaning of equipment, sterilizing filters, manufacturing equipment and utility support systems. Prepared Annual Product Reviews for a period of 6-months, for a client site focused on the manufacture of transdermal systems. Extensive experience with preparing companies for FDA Pre-Approval inspections. Hands-on experience with designing & building Quality Systems Associate Director, Drug Compliance Biogen Idec Oceanside, California Organized and managed commercial drug compliance functions for the Oceanside and La Jolla locations of Biogen Idec. Directed strategic, tactical and operational processes for this $1B corporation, with responsibility for compliance with regulatory licenses, CMC commitments, and internal procedures. Managed the site risk assessment team and served as a compliance expert on regulatory matters. Directed and participated in critical contract and vendor audits, as well as internal audits of a sterile biologics manufacturing facility. Supervised the work of the West Coast Drug Compliance Team with responsibility for management oversight and professional development Senior Compliance Consultant KMI, a division of PAREXEL International, LLC Laguna Niguel, California Performed GMP/FDA pre-approval (Mock PAI) and GMP/QSR audits of pharmaceutical and medical device organizations. Comprehensive audits included coverage of quality systems, including operational and risk assessments of equipment qualification and process validation activities. Wrote and presented reports providing strategic assessments, problems resolutions, and advice regarding management and legal counsel approaches to solve compliance matters, including strategies for short and long-term corrective and preventive actions. Performed organizational studies and reviews under attorney-client privilege, and provided compliance advice and assistance in FDA communications and interactions to

4 help avoid legal consequences. Examples of key accomplishments: Management of several medium to large GMP compliance projects (10-12 consultants, up to 3 weeks in duration) Numerous extensive reviews and evaluation of equipment and utility system qualifications, process and cleaning validation efforts and validation master plans. Expertise in evaluating various sterilization approaches including moist heat, filtration, ethylene oxide and gamma irradiation. Completed a number of audits and remediation activities at key clients manufacturing drugs, medical devices and biologics. Preparation of GMP improvement plans, compliance standards and audit checklists (e.g. Pre-Approval Inspections, Active Pharmaceutical Ingredients, HVAC qualification, corporate/site stability program) Preparation/review of 483 and Warning Letter responses to FDA, aseptic media fill protocols, 21 CFR Part 11 risk assessments Evaluation of new drug and device development activities Delivered a number of industry presentations on a multitude of GMP-related topics GMP Manager, Research Compliance Allergan Irvine, California Directed GMP compliance as well as internal and external auditing for all R&D areas involved in the drug and device development processes, primarily for ophthalmic products such as therapeutic drugs, intra-ocular lenses and lens care solutions. Successfully organized and trained audit organization. Prepared manufacturing sites for FDA pre-approval inspections. Managed and directed computer software quality assurance activities, delivering compliant software to operational use ahead of schedule. Examples of key activities and tasks include: Supervised and trained two GMP auditors. Assisted with audits of site clinical supply aseptic fill manufacturing operations, as well as R&D and QC Labs used to develop specifications, test raw materials, release testing and monitor product stability. Completed audits for operations developing and manufacturing intra-ocular lens and contact lens solutions. Reviewed CMC and Stability sections of NDAs, and performed audits against data intended to be submitted to FDA. Performed reviews of utility system qualifications for 2 newly constructed manufacturing facilities (sterile clinical supply pilot plant and commercial biological production site) Audits of software developers (document management system, laboratory information management system, and analytical instrument-driven software) Reviewed and/or approved in-house computer hardware and software IQ/OQ/PQ (requirements specifications, test plans/protocols, final reports, test scripts and raw data) for clinical patient database and environmental monitoring and control systems. Assisted in preparation of the BOTOX sterile bulk manufacturing facility for its first successful California state licensing inspection.

5 FDA Investigator Food & Drug Administration, Los Angeles District Office Irvine, California Performed drug GMP and Pre-Approval Inspections as a member of the District Drug Team and the Pacific Region NDA/ANDA Pre-Approval Inspection Cadre. Inspected finished drug product manufacturing operations for a variety of dosage forms, including sterile solutions produced by both aseptic processing (ophthalmics) and those terminally sterilized (LVPs); semi-solids; solid oral dosage forms (including tablets, and both hard and soft gelatin capsules), as well as inspections of medical device manufacturers. Attended FDA s resident Medical Device School. Performed two lengthy LVP training inspections with and FDA National Drug Expert. Inspected active pharmaceutical ingredient (API) manufacturers and contract test labs that performed both chemical and microbiological analyses. Worked with state and federal law enforcement officers over several years in conjunction with a large number of different criminal investigations. These investigations involved anabolic steroids, illegal importation of Chinese patent medicines, Prescription Drug Marketing Act violations and health fraud Quality Assurance Engineer American Racing Equipment Rancho Dominguez, California Conducted deviation investigations. Calculated scrap rates and performed supplier audits Quality Assurance Specialist (Ammunition Surveillance) Civilian Intern Program Savanna Army Depot, Illinois Attended an intensive resident course in rural Illinois for 8 months covering basic quality assurance principles, fundamentals of statistical process control (SPC), inspection and testing of ammunition, explosives and guided missiles. Military Experience U.S. Army Reserve/National Guard Served in leadership and staff positions as a commissioned officer, including company commander of a 240-person hospital unit. Attained the rank of Captain, Medical Service Corps. Honorably Discharged in Education Bachelor of Integrated Studies (Chemistry/Zoology/Physical Education) Weber State University Ogden, Utah

6 Training Criminal Investigator Training Program Federal Law Enforcement Training Center (FLETC), Glynco, Georgia Attended a 12-week course focusing on Constitutional and Criminal Law, Investigative Interviewing and Interrogation, Arrest Procedures, Execution of Search Warrants, Case Development, the use of Firearms, and Courtroom Procedures. Professional Organizations, Affiliations Parenteral Drug Association (PDA) Regulatory Affairs Professional Society (RAPS) Publications M.L. Balboni, Postmarketing Application Integrity: What is Data Integrity, and How to Ensure It?, Regulatory Affairs Focus, April 2006, pp M.L. Balboni, The Concepts and Principles Behind Process Analytical Technologies, Pharmaceutical Technology, October 2003, pp , , Welch, K. Weikert, and M. Balboni, Process Analytical Technology (PAT) Moving From Inspection to Prevention? PDA Letter, Volume XXXIX, No. 4, April M.L. Balboni and D.L. Chesney, Clinical Supplies Manufacture: GMP Considerations, Encyclopedia of Pharmaceutical Technology, Second Edition (Marcel Dekker, Inc., Arlington, Texas). DOI: /E-EPT (2002). (Web-based publication) M.L. Balboni, Keys to Quality Systems for Handling Investigations. Investigating, Documenting and Resolving Problems, BioPharm. 14, (2001). Other Have traveled extensively throughout the US (including Puerto Rico), and abroad (France, Italy, Germany, Austria, Belgium, Ireland, England, Sweden, Denmark, Switzerland, Scotland, Australia, India, Singapore, Malaysia, Thailand and Turkey). An avid long distance runner, having completed five (5) full marathons and 20+ half-marathons.