*** CAPA Manager – Project Manager for Site Remediation and Gap Analysis Support:

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• 22 weekly scheduled 4-hour remote CAPA Manager meetings & gap analysis updates with meeting minutes and Gantt reports

• FDA / ISO Emergency onsite Back Office Audit Support 2 days (or 2 days Mock Audit) (16 hours)

• Three (3) days GMP Gap Analysis Audit (1 Draft and 1 Final Report) or, Four (4) days onsite Audit Follow up, Remediation to Resolution Consulting.

• 20 hours of CAPA Manager online SME Support 24 hours a day, 7 days a week.

• Monthly One (1) day 10 hours, onsite Consulting and Quality Meetings – Remediation verification

• Access to the SOPLibrary.com at Capamanager.com – Up to 15 Templates (SOPs & Manuals)

• GANTT Management and Project Manager – Review, Update and Quality Meeting Minutes

• SME Support for Procedures and Templates as per Gap Analysis (IT, Part 11, Validation, etc.)

• Free Quality Management System Tool – Spreadsheet with Procedures.

• Supporting QMS Follow up and remediation assistance for, but not limited to:

  • CAPA (Corrective and Preventive Actions)

  • Nonconformance

  • Deviations

  • Complaints

  • Change Control

  • Audit Management

  • Documentation Control

  • Vendor Qualification Management

• One (1) day onsite GXP Training by GMP Boot Camps SMEs – 6th or 12th Month.

• Training materials include 10 sets (Additional Sets available at $50.00 per set):

  • Binder Workbooks – 300+ slide workbook

  • Pharmaceutical Master Guide - Over 900 pages.

  • Training Certificate for each Attendee

  • Monthly GMP Training for all new employees post initial training (Remote Training)

• Audit – Follow up onsite 1-day GMP Audit – 6th Month. (1 Draft and 1 Final Report) (8 hours)