top of page
FDA-Bldg-SignWeb_edited.jpg

Retain a Dedicated CAPA Management Representative
With the Support Staff You Require!

CAPAManager-TKGMP-2-1000-FDA.jpg

Your Quality Assurance, Regulatory Affairs & CAPA Manager Support Team
On-site When You Need Us!  Your FDA / EMA / ISO Audit Support Team!

Need a Self Assessment?

Issued an FDA Violation?

New Company Start-up?

CAPA Manager 6 / 12 Month Plans
Without Turnkey GMP / QMS

***CAPA Manager – Project Manager for Site Remediation & Gap Analysis Support - Your Quality & Regulatory Support Manager:

 

Provide Quality Management CAPA Support to satisfy FDA GMP Compliance:

  • Weekly scheduled 4-hour remote CAPA Manager meeting & Gap Analysis updates with Meeting & Gantt Reports.

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

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

  • 3-day SME Remote Document Reviews & Document Gap Analysis
  • GANTT Management & Project Manager – 6-Months***

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

  • FDA Emergency on-site Back Office Support 2 days (or 2 days additional Mock Audit)

 

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.

6 Month Plan - $44,995.00
12 Month Plan - $79,995.00

***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.

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

  • Additional hourly rate for SME 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.

  • 75% retainer required upon commencement of project with 25% due on the 3rd month, and remainder on the 6th month.

CAPA Manager 6 & 12 Month Plan with TurnKey GMP / QMS

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

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

  • Audit – On-site 3-day Commencement Audit (With Report)

  • Weekly scheduled 4-hour remote CAPA Manager meeting & Gap Analysis updates with Meeting & Gantt Reports.

  • Up to 25 – Quality Assurance SOPs (see CAPA Manager)

  • 3-day SME Document Review and Document Gap Analysis 

  • Access to Templates on GMP Help Desk 

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

  • Quality Assurance Manual or Manual updates
  • Up to 6 – Computer Systems & 21 CFR Part 11 SOPs

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

  • Audit – 1-day onsite GMP Audit – 6th Month.

  • FDA Emergency on-site Back Office Support up to 2 days (or 2 days additional Mock Audit)

 

Training materials includes 10 sets (Additional Sets available):

  • Binder Workbooks – 300+ slide workbook

  • GMP Handbooks  - 900+ pages.

  • Certificate for each Attendee

  • Monthly GMP Training Webinar for new employees.

6 Month Plan - $59,995.00
12 Month Plan - $89,995.00
Same Plan as 6-months plus...
  • ​Up to 30 – Procedures (see CAPA Manager)

  • Up to 10 – Computer Systems & 21 CFR Part 11 Procedures

  • Audit – 2-day on-site GMP Audit – 6th Month.

  • Audit – 1-day on-site GMP Audit – 12th Month.

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

  • FDA Emergency on-site Back Office Support up to 4-days (or 2 days additional Mock Audit)

  • Training Material Sets up to 20 Attendees

Gantt Driven QMS Project Management
140926-Gantt_Page_1x300.jpg

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.

483help1-TKGMP-2-1000.jpg
bottom of page