Abbass Kamalizad

    Abbass Kamalizad (Dr. K.) is the founder and president of ACPC Group, a consulting organization helping pharmaceutical industries
    in building and overhauling quality management systems, QA & QC for all phases of drug development and manufacturing. His
    experiences span over 20 years in establishing quality systems, drug development and manufacturing, QC/QA and R&D
    laboratories in support of submission.

    Dr. K joined Pharmaron (a CRO in Beijing China) in March 2009 as the VP of Quality Assurance and Regulatory Affairs. He also
    served as Laboratory Director (QC and Analytical R&D) at Anchen Pharmaceuticals. Both positions were assigned from ACPC
    Group.

    He served as the Sr. Director of Laboratory Services, IAL (now IPS), and as a Sr. Scientist and Lab Director at AAI (now AAI
    Pharma). He taught and researched in universities for 15 years with research interest in chiral chemistry and chiral
    chromatography. He received a B.Sc. in chemistry from Tehran University and a Ph. D. in analytical chemistry from University of
    Massachusetts.
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Instructors
Shib Mookherjea

    Shib Mookherjea has a proven track record in Analytical Development, QA/QC, R&D and extensive accomplishments in the areas of
    Pharmaceutical Development (ICH Q6, Q7A, Q8), Training, Management of QA/QC, Process Upgrade, Auditing, PAT applications, Validation
    in the laboratory (Methods, Systems, Equipment Qualification), and support for dosage forms, in process materials, excipients, DS, DP,
    medical devices, etc. He has held Management and supervisory positions within Pharma, Biotech and other companies including Allergan
    Medical, Colgate Palmolive, Johnson & Johnson, Troy Corporation, BASF & CRO/CMO Laboratories.

    Time tested coordination and leadership ability paved ways to build and develop functional groups from the ground up, while ushering in
    systems, procedures, documentation and implementation of quality systems (GLP, cGMP, ISO 17025) and other international standards for
    regulatory compliance.  Such challenges have been successfully met in various corporate settings by providing the needed training and
    guidance, utilizing the world-wide network of scientific professionals that remain an excellent source of reference and assistance in problem
    solving.

Dr. Dr. Mookherjea is the Principal of ValQual International, Inc. and has developed over 15 Training Modules and customized Training Sessions. He is a highly-
recognized speaker and provides global training and consulting in areas of Validation, Qualification, CAPA, Methods & Audits for GMP, GLP (FDA/OECD), and ISO
17025. Over the last 20 plus years, he has conducted hundreds of these training sessions in more than 25 countries to more than 8000 attendees.
Frederick Klink

    Fred received a degree in biochemistry from Northwestern University and completed graduate studies in forensic chemistry at the
    University of Illinois. He spent seventeen years in the analytical instrument business where he held positions as an applications chemist,
    development project manager, product manager, marketing manager, and manager for strategic planning. Fred has been teaching highly
    regarded courses in mass spectrometry, solid-phase extraction, and protein analysis since 1996.

    Fred's specialty is HPLC and SPE technologies and the application of mass spectrometry to protein characterization.  Fred is the author of
    several journal articles and two book chapters: one on LC/MS for the Encyclopedia of Analytical Chemistry (Wiley, 2010) and another on
    chromatography systems in Cunico, Gooding, And Wehr, Basic HPLC and CE of Biomolecules (BBL, 1998). Fred is also a principal
    contributor to the monthly column MS Solutions. He is a member of the American Chemical Society and American Society for Mass
    Spectrometry.
Martin Jenkins

    Martin Jenkins, PMP, is the current President and a Sr. Consultant with Circle MJ Consulting, LLC; a Maryland based consulting firm
    specializing in Program and Project Management, Process Validation, Cleaning Validation, Quality Systems, New Technology
    Development, and Information Technology; serving clients such as Hospira Inc., Covidien, Mallinckrodt Pharmaceuticals, Intarcia
    Therapeutics, the International Pharmaceutical Academy, BNS Solutions, Mullins-Hill Consulting,
    and The ProPharma Group.

    He was the former Director of Operations for United Health and Wellness; a Virginia based clinical research and patient treatment
    corporation. Chief Operations Officer for the Golden Beam Corporation, a New York based nutriceutical and pharmaceutical company.  
    He previously served as a Project Management, Operations, and Quality Consultant for Golden Beam, for over three years.  He has also
    held positions as Senior Project Manager, Project Scientist, Sr. Scientist, The Analytical Methods Validation Site Leader, a Certified
    Process Validation Trainer, a Validation Practitioner, Chemistry Group Leader, and a Chemical Hygiene Officer at BD Biosciences, a New
    Jersey Based biotechnology company.  

Jenkins has multiple certificates from both participating in and instructing in Project Management workshops, Validation workshops and training classes at multiple
locations throughout the U.S. and Canada. He has managed a multitude of Technology Development Programs, R & D Projects, cGMP Projects, multiple Chemistry
Laboratories, Employee Teams, and High Level Project Teams in the Pharmaceutical, Nutriceutical, Medical Diagnostic, Medical Device, Microbiological, Molecular
Biological, and Analytical Chemistry fields. Prior to that position he has spent nine years managing projects as an analytical chemist in the Active Pharmaceutical
Ingredient manufacturing section of Abbott Laboratories. He has also worked over four years for the U.S. Drug Enforcement Administration where he was a
Forensic Chemist.

He has over 22 years of Technology Development Leadership, Program Management, Project Management and Process Validation experience split between R&D
and Quality Assurance/Regulatory Affairs, and Manufacturing Operations.  

He also holds a current project management professional certification (PMP) from the Project Management Institute, a Masters Degree in Analytical Chemistry from
Illinois Institute of Technology, and a Bachelors Degree in Chemistry from Howard University, as well as graduate certificates from Penn State, Towson State, and
University of Massachusetts respectively in the fields of molecular biology, microbiology and analytical instrumental analysis.
Abbass Kamalizad

    Abbass Kamalizad (Dr. K.) is the founder and president of ACPC Group, a consulting organization helping pharmaceutical industries
    in building and overhauling quality management systems, QA & QC for all phases of drug development and manufacturing. His
    experiences span over 20 years in establishing quality systems, drug development and manufacturing, QC/QA and R&D
    laboratories in support of submission.

    Dr. K joined Pharmaron (a CRO in Beijing China) in March 2009 as the VP of Quality Assurance and Regulatory Affairs. He also
    served as Laboratory Director (QC and Analytical R&D) at Anchen Pharmaceuticals. Both positions were assigned from ACPC
    Group.

    He served as the Sr. Director of Laboratory Services, IAL (now IPS), and as a Sr. Scientist and Lab Director at AAI (now AAI
    Pharma). He taught and researched in universities for 15 years with research interest in chiral chemistry and chiral
    chromatography. He received a B.Sc. in chemistry from Tehran University and a Ph. D. in analytical chemistry from University of
    Massachusetts.
Abbass Kamalizad

    Abbass Kamalizad (Dr. K.) is the founder and president of ACPC Group, a consulting organization helping pharmaceutical industries
    in building and overhauling quality management systems, QA & QC for all phases of drug development and manufacturing. His
    experiences span over 20 years in establishing quality systems, drug development and manufacturing, QC/QA and R&D
    laboratories in support of submission.

    Dr. K joined Pharmaron (a CRO in Beijing China) in March 2009 as the VP of Quality Assurance and Regulatory Affairs. He also
    served as Laboratory Director (QC and Analytical R&D) at Anchen Pharmaceuticals. Both positions were assigned from ACPC
    Group.

    He served as the Sr. Director of Laboratory Services, IAL (now IPS), and as a Sr. Scientist and Lab Director at AAI (now AAI
    Pharma). He taught and researched in universities for 15 years with research interest in chiral chemistry and chiral
    chromatography. He received a B.Sc. in chemistry from Tehran University and a Ph. D. in analytical chemistry from University of
    Massachusetts.
Gary Ritchie

    As an internationally recognized expert in pharmaceutical analysis, process analytics and quality assurance, Gary’s experience
    includes 19 years with increasing responsibilities in quality control, technical services, research and development and new
    technologies. Gary serves as a consultant with The Quantic Group, QualComp, Compliance Insight and The FDA Group providing
    analytical and quality solutions for diverse companies operating in the pharmaceutical manufacturing sector. He continues to serve
    as Consultant/Director of Scientific Affairs for InfraTrac, a service provider, assisting in the development of novel anti-counterfeiting
    solutions for various industrial applications. Gary served as Scientific Fellow for Process Analytical Technology and Liaison to the
    General Chapters, Pharmaceutical Waters and Statistics Expert Committee’s from 2003 through 2008 for the United States
    Pharmacopeia (USP). As a USP in-house expert on the Food and Drug Administration (FDA) Process Analytical Technology and
    Quality by Design Initiative, he was responsible for over thirty Pharmacopeial chapter revisions that incorporated and reflected the
    revisions by the FDA on the 21st Century cGMP Initiatives. He also led collaborations on several FDA, USP and industry projects
    that resulted in several Pharmacopeial standards. Gary has more than thirty peered reviewed papers and book chapter
    contributions; five issued patents, numerous industry journal articles and has been an invited speaker at many conference and
    symposia worldwide.  He was President of The Council for Near-Infrared Spectroscopy (2012-2014).

Gary’s combined experience in private industry and non-government agency has allowed him to quickly see through many challenges confronting pharmaceutical
and compounding pharmacies and provide solutions that address patient safety and business efficiencies. Gary has a deep appreciation for regulatory science.
This coupled with his hands on experience in pharmaceutical and process analysis allows him to think tactically in providing solutions that are both practical and
compliant, something not easily achieved without someone with his background. Gary has demonstrated leadership, management and organization skills at both the
domestic and international levels having led a 47 member consortium of pharmaceutical industry and regulatory bodies to revise a national standard for the USP as
well chair committees for the Association for Standards and Technical Materials (ASTM International) and the International Diffuse Reflectance Conference (IDRC).