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New Company Start-up?

Issued an FDA 483 or Warning?

Need a Self Assessment?

Get a Quick Turn-Key GMP System Compliant to meet & Exceed FDA Requirements

Audit, Gap Analysis, SOP Templates & Training - Managed by CAPA Management FDA SMEs

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Protect your Company!

Turn-Key GMP & QMS Readiness

Turn-key solutions to get your company up and running within a CGMP Controlled Environment, avoiding FDA violations or Warning Letters. 

 

  • Get your products to the market faster.

  • Avoid Company Liability

  • Envision Your Return On the Investment (ROI)

  • Operate in a State of Control with Confidence!

FDA Subject Matter Experts

Seeking a quick resolution to your 483s or Warning Letters? Let us help, fast and discretely.

CAPA Manager 6 Month Plan

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

 

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

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

  • 25 – Quality Assurance SOPs (see CAPA Manager)

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

  • Quality Assurance Manual or Manual updates

  • 10 – Computer Systems & 21 CFR Part 11 Compliance SOPs

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

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

 

Training materials includes 10 sets (Additional Sets available):

  • Binder Workbooks – 300+ slide workbook

  • GMP Handbooks or Medical Device Master Guide - 900+ pages.

  • Certificate for each Attendee

  • Monthly GMP Training Webinar for new employees.

 

$26,000.00

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Gantt Driven QMS Project Management
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CAPA Manager 12 Month Plan

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

 

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

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

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

  • 40 – Quality Assurance SOPs (see CAPA Manager)

  • 10 – Computer Systems & 21 CFR Part 11 Compliance SOPs

  • 1 – Quality Assurance Manual or Manual updates

  • 6 – Validation Procedures

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

  • Audit – 2-day on-site GMP Audit – 6th Month. (1 Draft / Final Report)

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

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

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Training materials includes 20 sets (Additional Sets available):

  • Binder Workbooks – 300+ slide workbook

  • GMP Handbooks or Medical Device Master Guide - 900+ pages.

  • Certificate for each Attendee

  • Monthly GMP Webinar Training for new employees.

 

$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/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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