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Gantt Driven QMS Project Management
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CAPA Manager 6 Month Plan

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

Provide applicable SOPs, and QMS templates to satisfy FDA GMP Compliance:

  • Audit – On-site 2-day GMP Audit (1 Draft and 1 Final Report)

  • 25 – Quality Assurance SOPs (see CAPA Manager)

  • 2-day on-site GXP Training by GMP Boot Camps SMEs – 1st  Month.

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

  • Binder Workbooks – 300+ slide workbook

  • GMP International Master Handbook, or Medical Device Master Guide - 900+ pages.

  • Certificate for each Attendee

  • Monthly GMP Training for all new employees post initial training.

  • Quality Assurance Manual or Manual updates

  • 10 – 21 CFR Part 11 Compliance SOPs

  • GANTT Management and Project Manager – 6-Months***

  • Audit – Follow up on-site 1-day GMP Audit – 6th Month. (1 Draft and 1 Final Report)

 

$26,000.00

CAPA Manager 12 Month Plan

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

Provide applicable SOPs, and QMS templates to satisfy FDA GMP Compliance:

  • On-site 3-day GMP Audit  (1 Draft and 1 Final Report)

  • 2-day on-site GXP Training by GMP Boot Camps SMEs – 1st  Month

Training materials includes 20 sets (Additional Sets available at $50.00 per set):

  • Binder Workbooks – 300+ slide workbook

  • GMP International Master Handbook, or Medical Device Master Guide - 900+ pages.

  • Certificate for each Attendee

  • Monthly GMP Training for all new employees post initial training.

  • 50 – Quality Assurance SOPs (see CAPA Manager)

  • 10 – 21 CFR Part 11 Compliance SOPs

  • 1 – Quality Assurance Manual or Manual updates

  • 6 – Validation Procedures

  • GANTT Management and Project Manager – 12-Months***

  • 1 – Audit – Follow up on-site 1-day GMP Audit – 6th Month. (1 Draft and 1 Final Report)

  • 1 – Audit – Follow up on-site 1-day GMP Audit – 12th Month. (1 Draft and 1 Final Report)

  • 2-day on-site GXP Training by GMP Boot Camps SMEs – 12th Month

 

$48,995.00

***CAPA Manager

  • Includes remote weekly 4-hour CAPA Manager meeting, Gap Analysis updates and Gantt PM reports.

Additional months can be purchased for $2,995 per month over Project Scope. Span across 2 days.

  • Includes 4 hours of customization per procedure to satisfy the customer’s requirements.

  • Additional procedures will be provided for $995 each with 4 hours of customization.

  • Additional hourly rate for SME document modifications will be billed at $295.00 per hour.

  • Quality Management Systems are available for quote. Microsoft Excel spreadsheets are available for free upon contract. Call for details.

  • 50% retainer required upon commencement of project with 25% due on the 3rd month, and remainder on the 6th month.

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