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US & EU GMP REGULATORY INTELLIGENCE & GMP AUDITINGDepth of experience in GMP auditing including evaluations of data management and data integrity. Led corporate GMP auditing effort for APIs, quality systems and computer systems.Developed and implemented comprehensive GMP Regulatory Intelligence program within Fortune 500 pharmaceutical company. Deep understanding of history and intent of GMP requirements. Ability to interpret requirements and impact of potential changes and trends. Able to quickly identify and analyze new GMP enforcement requirements and trends. Areas of expertise include:• GMP Auditing• GMP Enforcement• GMP Enforcement Trends • GMP Regulatory Intelligence• Drug Recall Trends• Device Recall Trends• GMP Training• Policy Issues & Interpretation• Advocacy StrategiesSELECTED ACCOMPLISHMENTS• Provided Quality consulting services to the Pharmaceutical and biotech industry including GMP auditing and remediation. Led corporate GMP audit program responsible for APIs, Quality Systems and computer systems.• Developed, implemented and maintained comprehensive GMP Regulatory Intelligence program within Amgen Inc. for eight years, including surveillance, analysis and communication of new or revised legislation, regulations, guidance and GMP inspection trends for major regulatory jurisdictions.• Founding chairperson and 5 year leadership of Rx-360 working group for GMP/GDP Intelligence Reporting. • Led GMP Intelligence subgroup of the Midwest Discussion Group 2010-2014. Please contact me at: bwunger123@gmail.com
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PresidentUnger Consulting, Inc. 2015 - PresentLos Angeles, UsUnger Consulting Inc. can assist with your GMP auditing, including the areas of data management and data integrity. My background includes deep working experience in this area including:-- Expertise auditing GMP manufacturing sites focused on data governance and data integrity.-- Lead the Corporate GMP audit group responsible for audits of APIs, and Quality Systems and performed audits for pharmaceutical companies as a consultant, including audits focused on data management and data integrity in the QC laboratory. -- Broad background in GMP interpretation gained over years of GMP auditing pharmaceutical facilities, monitoring legislation, guidance and warning letters and GMP inspection reports-- Developed, implemented and maintained comprehensive GMP Regulatory Intelligence program for a large international biopharmaceutical firm for eight years, including surveillance, analysis and communication of new or revised legislation, regulations, guidance and GMP inspection trends for major regulatory jurisdictions.-- Founding chairperson and 5 year leadership of Rx-360 working group for GMP/GDP Intelligence Reporting, 2009-2014. -- Led GMP Intelligence subgroup of the Midwest Discussion Group 2010-2014.-- Co-lead of the Data Integrity Working Group in Rx-360 Consortium -
Principal ConsultantValidant 2015 - Present
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Lead For The Monitoring And Reporting GroupRx-360 2009 - 2014Philadelphia, Pa, Us -
Director, Corporate Quality ComplianceAmgen Inc 2004 - 2014Thousand Oaks, Ca, UsDirector, External Quality, 2009-2014Director, Corporate Quality Compliance, 2006-2009Developed, implemented and maintained a comprehensive GMP Intelligence program for 8 years. Included surveillance, analysis and communication of new or revised legislation, regulations, guidance and GMP inspection trends for major regulatory jurisdictions. • Published bimonthly newsletter with readership of >1000 Amgen staff. • Special data collection and analysis for Quality Senior Vice President.• Led or participated in industry trade group efforts to influence regulatory authority policy decisions.• Founding Chairperson of the Monitoring and Reporting work stream of Rx-360 Supply Chain Trade Organization (2009 – 2014).• Chairperson of the GMP-Intelligence Subgroup of the Midwest Discussion Group (2010-2014).Associate Director, Corporate Quality Compliance, 2004-2006Led group of up to six auditors responsible for internal audits of Active Pharmaceutical Ingredients (API) manufacturers, both Amgen owned and contract manufacturers located outside the US. Audited Corporate Quality Systems. Scheduled, coordinated and conducted audits, wrote reports, assigned criticality, followed up corrective actions, developed and communicated metrics / issues to management. -
Principal ConsultantDon Hill And Associates 2001 - 2004Consultant to Biologics and Pharmaceutical industries regarding CGMP Compliance, Quality Programs and CMC aspects of Regulatory Affairs.Principal Consultant• Assisted mid and large cap pharmaceutical clients in development and implementation of Quality System improvements. • Performed mock inspections as preparation for regulatory agency inspections, developed gap analysis and prioritized remediation activities.• Assisted clients responding to FDA 483 inspection observations and warning letters.
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Regulatory Affairs / Quality AssuranceEli Lilly And Company 1994 - 2001Indianapolis, Indiana, UsAssociate Regulatory Consultant, Quality Unit, 2000-2001Developed and implemented project management plan to prepare both company owned and contract manufacturing sites for pre-approval inspection (PAI) for a novel recombinant protein product.Associate Regulatory Consultant, Regulatory Affairs, CMC,1996-2000Senior Regulatory Representative, Regulatory Affairs, CMC, 1994-1996Responsible for global CM&C and facility regulatory issues for selected biotechnology pharmaceuticals. Developed regulatory plan and strategy relative to CM&C and facility issues ensuring that regulatory issues align with other areas within the project team. Served as technical mentor to new department members assigned to biotechnology products.• Coordinated, wrote and edited CM&C sections of regulatory submissions such as IND’s, IND amendments, CTX, annual reports and BLAs or NDAs for the development phase project teams.. Additionally, coordinated interaction with FDA reviewers as needed to resolve issues• Provided due diligence assessment of potential joint business ventures for Business Development group, provided input on structure of contractual agreements for joint ventures. -
Senior ScientistHybritech, Inc. 1980 - 1994
Barbara Unger Skills
Barbara Unger Education Details
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University Of Illinois Urbana-ChampaignChemistry
Frequently Asked Questions about Barbara Unger
What company does Barbara Unger work for?
Barbara Unger works for Unger Consulting, Inc.
What is Barbara Unger's role at the current company?
Barbara Unger's current role is Retired.
What is Barbara Unger's email address?
Barbara Unger's email address is bu****@****gen.com
What is Barbara Unger's direct phone number?
Barbara Unger's direct phone number is (805) 447*****
What schools did Barbara Unger attend?
Barbara Unger attended University Of Illinois Urbana-Champaign.
What skills is Barbara Unger known for?
Barbara Unger has skills like Gmp, Pharmaceutical Industry, Regulatory Affairs, Fda, Quality System, Biotechnology, Biopharmaceuticals, Quality Assurance, Gxp, Cmc Regulatory Affairs, Regulations, Capa.
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