Arleen Candari Email & Phone Number

Global

Greater Bay Area

WPO is the premier membership organization for women presidents and CEOs of privately held, multi-million dollar companies. The East Bay Chapter is composed of accomplished women leaders from diverse industries who address business concerns in a roundtable format and function as an informal board of directors for their businesses.

San Francisco, California

Since 2003, sole owner and principal of the C&A Consulting firm. Consulting support is provided to sites/companies, which include:-Bayer Healthcare, Emeryville, CA-Black Diamond Networks, Andover, MA-Comentis, South San Francisco, CA-DataSweep, Mountain View, CA-Eichleay Engineers, Concord, CA-Genentech, South San Francisco, CA-Genentech, Oceanside, CA-Genentech, Vacaville, CA-Genentech, Hilsboro, OR-Gilead, Foster City, CA-Impax, Hayward… Show more Since 2003, sole owner and principal of the C&A Consulting firm. Consulting support is provided to sites/companies, which include:-Bayer Healthcare, Emeryville, CA-Black Diamond Networks, Andover, MA-Comentis, South San Francisco, CA-DataSweep, Mountain View, CA-Eichleay Engineers, Concord, CA-Genentech, South San Francisco, CA-Genentech, Oceanside, CA-Genentech, Vacaville, CA-Genentech, Hilsboro, OR-Gilead, Foster City, CA-Impax, Hayward, CA-Impax, Philadelphia, PA-Parexel, Global-Processes Unlimited International, Inc., Bakersfield, CA-Roche, Ltd., Basel, Switzerland-Skanska, Global-The DiLisi Group, Denver, CO-Zymogenetics, Seattle, WA-Novartis-Glaxo Smith Kline-Baxter-Wyeth-Systec-Pfizer-Rockwell Automation Show less

C&A Team supports Project Management, Change Control Management, Risk Management and Validation Activities for equipment systems.

Ms. Candari provides strategic compliance support to Parexel, who are among the top leaders and ex-FDA regulators on GMP Audits and Inspections. Support includes the following: -GLP, GCP and GMP Compliance Strategies-GLP, GCP and GMP Audits & Assistance-Pre-approval Inspection (PAI) and Regulatory Audit Inspection Readiness Training-Third Party or Supplier Audits and Assessments-Quality and Compliance Governance Assessments and Loaned Executives-Due Diligence of… Show more Ms. Candari provides strategic compliance support to Parexel, who are among the top leaders and ex-FDA regulators on GMP Audits and Inspections. Support includes the following: -GLP, GCP and GMP Compliance Strategies-GLP, GCP and GMP Audits & Assistance-Pre-approval Inspection (PAI) and Regulatory Audit Inspection Readiness Training-Third Party or Supplier Audits and Assessments-Quality and Compliance Governance Assessments and Loaned Executives-Due Diligence of Potential Product and Facility Acquisitions-Assistance during inspections and with post-inspection correspondence and meetings-Assistance to legal counsel in FDA enforcement matters Show less

Ms. Candari project managed a team of consultants in the Gap Assessment/Remediation and Validation for all site GMP utilities and equipment, resulting on the successful closure of several hundred critical gaps.

Ms. Candari provided consulting services to the following companies:-Genentech, South San Francisco, CA-Baxter, Thousand Oaks, CA-Berlex, Richmond, CA-Idec, San Diego, CA-Wyeth, Andover, MA-Bayer Diagnostics, Emeryville, CA-Cor Therapeutics, South San Francisco, CA-Nektar, San Carlos, CA