Team

Jeff Yuen & Associates has been very fortunate to attract a wide range of skilled and experienced individuals. Our associates each bring long years of expertise and excellence from a wide variety of backgrounds. We are confident that we can assist you with our comprehensive set of skills.

Jeff Yuen
Jeff Yuen

President and CEO/Founder

CDR Jeff Yuen is a well-respected domestic and international speaker with over 25 years of compliance and regulatory experience. Jeff was a peace officer/investigator with the State of California, Food and Drug Branch and a Consumer Safety Officer for the U.S. FDA. During his tenure with the U.S. FDA, he was rapidly promoted to the rank of Commander in the U.S. Public Health Service while serving as a member of the following teams:

  • FDA’s Pacific Regional Biotech Team (pre-cursor to ORA Team Biologics)
  • Los Angeles District Pre-Approval Manager and Drug Team Leader
  • Foreign Inspection Cadre

CDR Yuen served as District Drug Team Leader and Drug Pre-Approval Manager during his time with U.S. FDA. CDR Yuen specialized in both high priority drug (PAI) and biologics (ELA and BLA) inspections. He is widely recognized as a CGMP and compliance expert in the industry, including CDER and CBER Office of Compliance in the area of sterile drug manufacturing, particularly with regard to inspection of biotech products, aseptic filling, quality systems, and process validation.

CDR Yuen is the recipient of numerous U.S. Public Health commendation and achievement medals including a “Hammer Award” presented by Vice President Al Gore’s office for his participation and leadership in the area of innovative biotechnology/FDA industry outreach programs. Since leaving the FDA in 1998, CDR Yuen has succeeded in launching a well-recognized and well-respected independent consulting firm. Jeff Yuen & Associates, Inc. is comprised of a unique balance between former FDA National Experts, specialists, investigators, chemists, biologists and microbiologists AND former industry quality systems, compliance and GXP regulatory experts.

CDR Yuen has become well-recognized worldwide for his unique ability to work well with others in Operations and QA. Well-respected for his mentoring, coaching and love for teaching, CDR Yuen excels at bringing out the best in companies. With a passion for operational excellence and performance, he has often served as the catalyst for organizational and cultural change, resulting in effective quality systems which emphasize the importance of "right first time" and proper root cause investigations and meaningful CAPA initiatives. CDR Yuen's leadership and insights, along with his endless energy and special charisma have influenced, shaped, and prepared many companies and their leaders for success during this challenging era of technological advancements and stricter compliance expectations.

Griet Atkins
Griet Atkins

Griet has 20 years pharmaceutical industry experience ranging from research and development to commercial production. Her experience in pharmaceutical start-up companies has led to her rapid career development and broad knowledge. Griet has worked on a spectrum of large-scale projects including patented controlled release technologies, development of new absorbable implants, commissioning of a new parenteral facility, and launch of first-to-market generics.

Griet has been a consultant with JYA since 2013. Her areas of expertise include cGMP auditing, quality investigations, quality systems remediation, CRO audits, and mock PAI.

Gary Brennan
Gary Brennan

Gary is a seasoned quality professional with more than 20 years of experience in Quality Assurance, Quality Control, Validation and organizational assessments. He has held leadership positions with both large and small companies including Teva, Mallinckrodt, AAIPharma and Cambridge Major Laboratories. Gary’s experience includes assessment and implementation of systems to optimize performance for both early stage clinical and commercial clients. He also excels at inspection preparation and QA training for organizations.

Andrew Campbell
Andrew Campbell

Andrew brings over 27 years of industry experience in Quality Assurance and Quality Systems to clients at Jeff Yuen and Associates, Inc. Andrew has worked with both direct and contract manufacturing models, in support of commercial and Phase I-III development activities. He has a strong background in quality systems design and implementation. His areas of expertise include Quality Systems Assessment/Remediation, Deviation/CAPA, Change Control, GMP Auditing, GMP Training, and Regulatory Inspection preparation and management.

Terri Dodds
Terri Dodds

After 24 years in uniformed service, Terri retired from the U. S. Public Health Service as a Captain. Sixteen of those years were spent with the U.S. FDA. She left FDA as a level 3 certified drug investigator/auditor and a member of the CDER Pharmaceutical Inspectorate.
Terri has been a consultant with Jeff Yuen & Associates since 2006. Her areas of expertise include drug and biotech GMP auditing and training, GCP auditing, performing warning letter and strategic regulatory consultation, performing CMO and CRO audits, and reviewing technology transfer, scale-up and validation plans.

Elvia Gustavson
Elvia Gustavson

Elvia has over 30 years of experience in the pharmaceutical industry in the specific area of Regulatory Affairs, with 10 years of consulting experience. Elvia has been a consultant with Jeff Yuen & Associates since 2006. Her expertise in Regulatory Affairs includes life cycle management of submissions from pre-clinical to post-marketing stages of API, and drug product development. Over her career, Elvia has developed a rapport with the U.S. FDA as an effective liaison for her clients both foreign and domestic. As a result, Elvia has the ability to work cross-culturally, especially in Latin America. She has supported projects to facilitate the Regulatory Affairs strategies for sterile drug products, oral dosage forms, and APIs.

Donald Harrigan
Donald Harrigan

Donald has over 30 years of pharmaceutical, biotechnology and medical device experience. Donald worked for several leading organizations where he directed on average four FDA inspections per year for 10 years, successfully conducted over 30 pre- and post-approval FDA inspections for new products and obtained 27 ANDA approvals.
Donald has been a consultant with Jeff Yuen & Associates since 2005. His areas of expertise include cGMP auditing and training, warning letter remediation and regulatory strategic consultation, and mock PAI. Donald also is an excellent resource for regulatory submissions preparation and review for INDs, BLAs, NDAs, ANDAs and CMC sections.

Chris Hartle
Chris Hartle

Chris Hartle has over 20 years of quality compliance experience in large and small biomedical companies as both an employee and consultant. His area of expertise includes compliance auditing, training, and quality management systems. As an auditor, he has extensive international experience performing GCP, GLP, and cGMP audits, mock inspections, and gap assessments of various forms of internal operations and management systems at clinical sites, laboratories, CROs, distribution centers, manufacturers, and various other types of regulated service providers. As a quality professional, Chris has assumed increasing levels of responsibility: he has worked in Europe as a Senior International Compliance Auditor for Sanofi-Synthélabo, and in Southern California as Head of Quality Assurance for both La Jolla Pharmaceutical Company, and Ambrx, Inc. Chris has been a consultant with Jeff Yuen & Associates since 2009. Chris holds a Masters of Sciences in Biomedical Quality Systems and instructs part-time as an adjunct professor for San Diego State University's Regulatory Affairs Professional Certificate and Masters Programs within the College of Sciences.

Jose Hernandez
Jose Hernandez

Jose Hernandez retired from the U.S. Food and Drug Administration (FDA) with 28 years of creditable service. During his tenure with the FDA, he served in several roles including investigator, compliance officer, laboratory analyst, trainer, and acting roles as a supervisory investigator and Director of Compliance. He was certified FDA Level III Pharmaceutical Investigator. He gained expertise in conducting Integrity Type investigations and graduated from the Federal Law Enforcement Training Center certified as a U.S. Federal Criminal Investigator with a Level 5 Secret Clearance. He was recognized as the FDA Investigator with ‘a nose for finding integrity issues’ and was credited for developing two Application Integrity Program cases during his career. He has performed over 100 inspections of pharmaceutical companies that expanded from inspecting key raw materials and APIs, to finished formulations including orals, liquids, sterile, patches, topicals, etc. His last five years with FDA were spent as an International Pharmaceutical Investigator, performing drug inspections including pre-approval and the most complex general GMP quality system inspections world-wide. Over the years, he successfully completed numerous training courses in FDA inspection and interviewing techniques, Quality Systems Inspections, and pre- and post-approval inspections applicable to the pharmaceutical, biotechnology, and medical device industries. He provided training to numerous FDA investigators on how to conduct pre-approval and cGMP inspections. He is fluent in both Spanish and English.

Calvin Koerner
Calvin Koerner

Prior to joining Jeff Yuen & Associates in 2009, Calvin was the Acting FDA Branch Chief for both CDER, Office of Compliance and the CBER Office of Compliance & Biologics Quality. Also while he was with the FDA, Calvin was the Lead Pre-Approval Inspector within the Office of Compliance for CBER/CDER where he led inspection teams on pre-licensing and pre-approval inspections for drugs, biologics and devices. Calvin received many awards while at the FDA, including the CBER Special Recognition Certificate for consistent, timely and exceptional review and inspections of multiple license applications and supplements leading.

Hyojong 'Hue' Kwon
Hyojong 'Hue' Kwon

Hyojong 'Hue' Kwon, Ph.D. worked for Office of Clinical Pharmacology (OCP), Office of Generic Drugs (OGD) and Office of Compliance (OC) for 8 years prior to joining Jeff Yuen & Associates. Hue was heavily involved in citizen petitions, establishing bioequivalence recommendations for generic drugs and evaluation of FDA 483s in clinical/bioanalytical studies.
She specializes in scientific evaluation for citizen petitions, analytical/bioanalytical laboratories for cGMP/clinical/bioequivalence studies, and Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) audits.

Steve Lane
Steve Lane

Steve is a seasoned international quality and operations executive with over 25 years of experience leading FDA and EMA regulated organizations (12+ years of international experience). He has a proven record in inspection management, compliance remediation, and quality strategy development and deployment with related process optimization. His expertise includes strategic senior level leadership (specifically in interim senior leadership roles) as well as US and international regulatory strategy development and implementation through 483/WL/CD/NOIR response and remediation across all dosage forms and product platforms. His work experience includes almost 20 years in pharmaceutical biotech industry, 7 years as adjunct graduate professor at Johns Hopkins University, and 9 years at the United States Pharmacopeia. His formal education is in Chemistry, Microbiology, and Biotechnology.

Rosalie Lowe
Rosalie Lowe

Rosalie has worked in the pharmaceutical industry for about 30 years, with over 25 years of experience in Regulatory Affairs positions managing submissions sent to U.S. FDA. Her subject matter expertise is in the generic drug industry, focusing on sterile parenteral products. Rosalie has the ability to provide regulatory strategies and solutions throughout the life cycle of drug product development including R&D development, clinical studies, drug application, commercialization, and post marketing. She possesses a strong knowledge of U.S. regulatory requirements for drug products with sensitivity to the impact of regulatory decision-making on business operations. Rosalie has also been trained as a Lean Six Sigma Black Belt and can leverage her Lean Six Sigma knowledge to provide solutions which focus on efficiency and risk mitigation.

Ellen Hargus Lieber
Ellen Hargus Lieber

Ellen is a pharmaceutical professional with over 25 years of experience in pharmaceutical, biopharmaceutical, vaccine and device industry Quality Assurance. Ellen is experienced in the quality management of the development, validation, manufacturing, testing, labeling and packaging of clinical and commercial products including injectables, solid oral dosage forms, small molecule and biological drug substances and vaccines. Ellen has demonstrated consulting expertise in the management of numerous remediation projects, including commercial product backlogs of Annual Product Reviews, batch review and release, and ANDA reviews. Ellen has extensive experience in the establishment of quality agreements and contract service provider audits.

Phil Lindeman
Phil Lindeman

Phil brings 34 years of experience as an FDA Investigator and Compliance Officer performing GMP inspections of pharmaceutical plants throughout the world. While at FDA, Phil inspected more than 200 pharmaceutical manufacturers. The 34 years with FDA were followed by 10 years as a GMP Compliance Consultant specializing in GMP audits, preparations for FDA pre-approval inspections, remediations of quality systems following FDA 483s and Warning Letters and third party certification of corrections following consent decrees and voluntary corrective actions.

He has led successful remediation efforts following Warning Letters or consent decrees which have always led to passing follow-up inspections. Phil continues to effectively prepare firms for FDA pre-approval inspections (PAIs) through mock FDA audits and/or by exposing employees to typical FDA interview questions. We are proud to report that FDA inspections following these PAI preparations have never resulted in significant findings or delay of the application approval.

Tammy Lucik
Tammy Lucik

Tammy brings to the JYA team 27 years of industry experience in Quality Management. She has held senior level executive positions and managed quality staffs of up to 200 employees. Tammy has directly managed Quality Operations, Quality Systems and Regulatory Compliance. She has lead FDA and International Regulatory Inspections for Multi-Site Global Operations. She has experience in the Quality Management of Contract Laboratories, API, and Drug Product Manufacturing. In addition to these accomplishments, she has a strong background in strategic business planning, team development, training and education.

Tammy is a pragmatic leader in implementing First in Class Quality Systems. She has had direct Quality oversight and experience with clinical and commercial API, solid oral and sterile injectable dosage form manufacturing operations. Tammy is a dynamic quality consultant specializing in remediation of systems, inspection readiness, interim quality management roles and team development.

Frederick Mayer
Frederick Mayer

Frederick brings over 30 years of industry regulatory and compliance experience at Ajinomoto, Pfizer and GlaxoSmithKline to Jeff Yuen & Associates. At those organizations, Frederick gained experience in developing quality systems, audit and inspection programs for GLP, OECD, GCP, and GMP compliance. His experience in preparing and directing FDA audits for these organizations is a tremendous asset for JYA clients. Frederick leverages his project management experience to help organizations improve quality and processes and reduce costs through the implementation of lean manufacturing strategies.

Kenneth Muhvich
Kenneth Muhvich

Ken has more than 35 years of experience as a microbiologist. He frequently conducts audits of sterile product manufacturing facilities, including their microbiology laboratories. He is often asked to provide advice regarding investigations into product sterility failures.

From 1992 to 1997, Ken was a Review Microbiologist at the U.S. Food & Drug Administration’s Office of Generic Drugs. While at the FDA, he performed more than six hundred sterility assurance reviews. While at FDA, Ken was awarded the FDA Commendable Service Award “for sustained superior performance in maintaining review consistency, quality, and productivity, and coordination of sterility assurance issues for the Office of Generic Drugs” and the FDA Scientific Achievement Award from the Office of Pharmaceutical Sciences for a Microbiologist – Excellence in Review Science “for exceptional contributions to review science as exemplified in the review of microbiological quality of drug products and the development of regulatory positions.” Ken is widely recognized as an expert in aseptic processing of sterile drug products.

Prior to working for FDA, he supervised the Clinical Microbiology Laboratory at Sinai Hospital in Baltimore, Maryland for ten years. He is currently Co-leader of the PDA Task Force responsible for writing the Technical Report for Blow/Fill/Seal technology. Ken has been a JYA-Micro-Reliance LLC Expert Microbiologist Affliate since 2002.

He holds a Bachelors degree in Health Science from the University of Delaware, a Masters degree in Medical Microbiology from West Virginia University, and a Doctor of Philosophy degree in Experimental Pathology from the University of Maryland.

Leslie Osmera
Leslie Osmera

Leslie has over thirty years of experience in Pharmaceuticals (biologics, vaccines and chemical derivatives; oral and solid dosage) and Medical Devices (i.e., Quality Systems and Design controls, 501k products, blood screening, combo products, clinical diagnostics, wound healing). She has specific expertise in Quality Assurance, Regulatory Compliance, Quality Auditing lead (21 CFR 211 & 820), CMO due- diligence evaluation and selection, Validation, Quality Control, Technical Support and Training. She has additional experience in Consent Decree remediation, quality system development and evaluation, GMP and GLP internal and supplier auditing, product release, investigation and CAPA, documentation systems and management. She also has experience in FDA and EU regulatory commitment response, remediation and verification. Leslie is a twelve year ASQ Certified Quality Auditor, and experienced in GMP and GLP training program development and as a lecturer. Leslie has been a JYA-EC Affiliate since 2014.

Gordon Pendleton
Gordon Pendleton

Gordon brings over 30 years of experience with various high/low volume technologies, Pharma/Bio-Sciences, Medical Devices (disposable/consumable, reusable/active devices, implants) and IVDs. Before becoming a JYA affiliate in 2012 he had a progressive career involving many different disciplines such as Regulatory Affairs (RA), Quality Assurance (QA), Lead Auditor for RC, QMS Lead, R&D, Technical Support, and Operations. He has extensive experience with Quality Risk Management, training including Six Sigma, Lean manufacturing, and risk assessment for Medical Devices. In addition, Gordon has served as a “Section Lead” in FDA Remediation and Improvement programs for several major U.S. Corporations. Additional specialties include CAPA, Validation, Process Controls, Risk Management and Verification activities. Gordon is experienced with U.S. FDA CFR 820 (PMA & 510k), CE marking, Health Canada, Japan (PAL), Korea, Taiwan, Brazil, Australia and other global market requirements. He is also a EO/Gamma/EB/AC Sterilization validation expert and Lead Assessor/auditor for ISO 13485/9001 and ISO 14001. Gordon has been a JYA-EC Affiliate since 2011.

Kenneth Pilcher
Kenneth Pilcher

Ken has worked in biopharmaceuticals for over 23 years and has expertise in sterile filling, solid dose, monoclonal antibodies, contract manufacturing, and large pharma settings. Ken's experience covers all aspects of Quality including deviation investigations, preparation of FDA 483 Responses and follow-up/remediation, CAPA, APR, change control, batch record review, and document control. Ken’s specializes in change control management, batch record review/release, quality oversight and review of qualification/validation activities, quality metrics and database programming. Ken has been a JYA-EC Affiliate since 2015.

Julie Roberts
Julie Roberts

Julie has more than 25 years of quality experience in the pharma industry having worked with vaccines, oral dosage forms, biotech, and API sites; for multi-national companies such as AstraZeneca, GSK and Eli Lilly. As an experienced microbiologist and Qualified Person, Julie brings a strong European and U.S. perspective having audited in over 46 countries to differing international standards. She has experience in new facility start-ups (pilot plants, commercial facilities and laboratory operations). More recently, she has been focused on the identification of data integrity issues and detailed compliance remediation plans, together with coaching, training and educating staff in preparation for FDA inspections and EMA/MHRA audits. She has extensive experience of working in: India, South Korea and China, as well as Europe and the U.S.

Tom Savage
Tom Savage

Tom has 36 years of distinguished service with FDA, including work as a pharmaceutical chemist specializing in chromatography, spectroscopy, and dissolution testing, and as the supervisor of the Seattle pharmaceutical laboratory, which provided analytical and inspectional service to the entire West Coast. He also served as the Deputy Director of the ORA science division in FDA headquarters, and as a Senior Policy Advisor in CDER Office of Compliance.
Tom has extensive experience with regulatory method requirements. He has coordinated and participated in numerous training sessions, performed inspections in multiple areas of the world, and coordinated numerous high-profile analytical projects.

Eleanor Sharp
Eleanor Sharp

Eleanor is a highly motivated quality professional with over 25 years of combined experience in Pharmaceutical and Medical Device Quality Systems. She has a working knowledge of multiple regulatory Quality Systems, including FDA and EMA. Eleanor has held senior positions as the Associate Director of Quality Operations and GMP Compliance, Associate Director of QA Operations, and Associate Director of QA Auditing. Her experience ranges from regulatory inspection preparedness, building Quality Systems, and conducting audits across the client's entire supply chain. Eleanor has been a JYA-EC Affiliate since 2015.

Destry Sillivan
Destry Sillivan

Destry retired from the United States Public Health Service after serving sixteen years at the FDA. His primary roles while at the FDA included regulatory review, inspection, and project management experience in both CBER and CDER, and included management experience at CBER (Team Leader-OCBQ, Division of Manufacturing and Product Quality). The latter experience involved technical oversight of all aspects of facilities CGMP review, equipment review, and inspections for products regulated by CBER, and he also performed final secondary review for all Branch memoranda. He was the Division senior subject matter expert for several functional review areas, including all aspects of pre-approval and pre-license inspections, container closure integrity, aseptic processing, environmental monitoring, lyophilization validation, and cleaning validation. Previously as a senior reviewer/inspector, he led review and, where necessary, inspection teams for numerous BLAs and BLA supplements, regulatory meetings, and other regulatory submissions (IND, DMF, 510k, PMA, ANDA, etc.). His career has included working with nearly all major pharmaceutical manufacturers, and numerous minor firms. Destry's previous experience also includes vaccine/molecular biology based research at the United States Army Research Institute of Infectious Diseases (USAMRIID).

Ajit Smih
Ajit Smih

Ajit has over 30 years of hands-on experience conducting technical due-diligence for business development and has extensive experience conducting vendor audits and mock PAIs. In addition to extensive GMP experience Ajit has conducted several GLP audits of non-clinical CRO's domestically and internationally and has conducted and managed GCP site audits in preparation for FDA PAI's. Ajit has been active in academia as an adjunct professor at UCSD and San Diego State University, where he teaches courses in GMPs, GLPs and QC/QA.

Paula Trost
Paula Trost

Paula served with FDA for over 23 years, 6 of those years as a Microbiologist and Biologics Investigator and 17 years as one of the original members of Team Biologics. She retired from FDA in December 2014 as a National Biologics Expert. Her experience on Team Biologics afforded expertise in regulatory affairs and GMP inspections of biopharmaceutical manufacturing, including aseptic processing and bioburden control processing of both bulk and final product for vaccines, biotechnologically derived therapeutics, plasma fractionated products, allergenics, and IVD products. She was also very active in training FDA personnel. Paula began working with JYA soon after retirement and has been active in assisting firms with corrective actions from FDA inspections, performing mock inspections, coaching during FDA inspections, and training employees.

Rebecca Waterbury
Rebecca Waterbury

Rebecca brings over 16 years of hands-on experience including pharmaceuticals, medical device, biologics, and combination products. She has firsthand experience with products regulated in the U.S. and internationally. Her specific expertise includes FDA 483/Warning Letter response and remediation, quality system investigation (NCR, NMR, deviation, CAPA), batch release, Quality System development and implementation, warehousing controls, supply chain, U.S. and OUS distribution, supplier controls, design controls, commissioning, qualification, validation, FAT/SAT testing, quality auditing, hosting external inspections, training, FDA inspection readiness training and preparation, new product launch/ product transfer, complaint handling, and project management. Rebecca has previously held positions in industry, including VP of Quality, Director of QC/QA, and Head of Regulatory Compliance and Quality Systems. She is a trained lead auditor and has completed internal and external audits for numerous companies around the globe (GMP, GLP, GCP, GDP). Rebecca has been a JYA-EC Affiliate since 2011.

Bob Westney
Bob Westney

Bob Westney has nearly 30 years of experience in the GMP industry, including Quality Control Microbiology, Quality Assurance and Regulatory Affairs. He has worked for biotechnology and pharmaceutical manufacturers, as well as pharmaceutical, cosmetic, and food contract testing laboratories. He holds a Master of Science degree from Temple University in Quality Assurance/Regulatory Affairs. He is Regulatory Affairs Certified (RAC), and is a Certified Manager of Quality/Organizational Excellence (CMQ/OE). He is a member of the Pharmaceutical Microbiology Forum (PMF), the American Society for Microbiology (ASM), the Parenteral Drug Association (PDA), the Regulatory Affairs Professional Society (RAPS), and a Senior Member of the American Society for Quality (ASQ). Currently, Bob is also President and Director of Quality and Operations for Cryologics Inc. specializing in formulating in-house microbial isolates into formats required for compendial tests. Bob has been a JYA-Westney & Associates Consulting Affiliate since 2016.

John Wiskerchen
John Wiskerchen

John brings nearly 40 years of experience with the FDA in positions of increasing authority to Jeff Yuen & Associates. Most recently, he was the Laboratory Director in Seattle where he managed a team of chemists, biologists, microbiologists and entomologists. While at the FDA, John received many awards for his distinguished service.
John has been a consultant with Jeff Yuen & Associates since 1999. His areas of expertise include GCP, GLP and GMP auditing and training, strategic regulatory consultation and warning letter remediation, and performing mock PAIs for a variety of products.

Mahshid Rad Zahedn
Mahshid Rad Zahed

Mahshid has over 28 years of Quality and Manufacturing operations experience in small-molecule pharmaceuticals, biologics and medical devices and has worked for such companies as GSK, Mallinckrodt, Baxter, Valeant and Allergan. Prior to launching her consulting career, she functioned as Global Vice President of Quality for Valeant Inc., Baxter Medication Delivery, and Allergan Medical. Additionally, she has extensive experience in directing Quality Operation Teams in North America, Asia, South America and Europe.

Mahshid has developed and implemented Global Quality Management Systems throughout the product life cycle (development, scale-up, commercialization, and post-market), and has provided critical leadership for organizations faced with global regulatory compliance issues and the need to build the right capabilities to support virtual and local operations.

Mahshid’s specialties are in quality systems architecture, quality assurance, design controls, risk management, supplier quality, mock regulatory inspection, and due diligence audit.

Key Accomplishments include, but are not limited to the following:

  • Developed and implemented several comprehensive Quality Management Systems including key elements such as Design Control, Risk Management, Purchasing Control, and Production & Process Control.
  • Attained Class II and III product CE marking and site ISO certifications.
  • Obtained manufacturing site approvals by EMA, SwissMedic, Health Canada, ANVISA, PMDA and FDA.
  • Obtained product approvals by submitting successful NDA, INDA, BLA, 510(k), or PMA.
  • Managed a Consent Decree.

Mahshid has a BS in biological engineering and is a certified ISO Lead Assessor. She is a member of the American Society for Quality, the Advanced Medical Technology Association and the Female Executives Work Group.

Endorsements from Alumni
Janet Burke
Janet Burke

Associate Emeritus (Distinguished Service)

"My 13 years with JYA was a wonderful new experience after my 32-year career with FDA. I had the opportunity to see the 'other side' of working toward cGMP compliance in the drug industry. It afforded me the chance to travel to many countries, and to learn from the best and brightest investigators in the consulting business. I miss working with my JYA family, but enjoy spending this time at home with my other family."

Dan Moskowitz
Dan Moskowitz

Associate Emeritus (Distinguished Service)

“JYA was a great opportunity to work with clients who are fully invested in being world class businesses. I really enjoyed the daily challenge of helping organizations to build sustainable workflows for GMP compliance as well as growing their business. My colleagues with JYA were all great to work with and I will always value my relationship with them and Jeff Yuen. The experiences I gained by working with JYA, both in work and in life, have served me very well as I continue my career in the life sciences industry.”