GMP - GCP - FDA, EMA, ISO & Vendor Audit & Remediation
U.S. Headquarters - In-Country China, India & South America GMP/GLP/GCP Auditors for Suppliers, CMOs and 'For-Cause' Audits!
01-856-437-5880
Retain a Dedicated CAPA Management Representative
With the Support Staff You Require!
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:
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Weekly scheduled 4-hour remote CAPA Manager meeting & Gap Analysis updates with Meeting & Gantt Reports.
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Audit – 2-day on-site GMP Audit (1 Draft / Final Report)
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2-day on-site GXP Training by GMP Boot Camps SMEs – 1st Month.
- 3-day SME Remote Document Reviews & Document Gap Analysis
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GANTT Management & Project Manager – 6-Months***
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Audit – 2-day on-site GMP Audit – 6th Month. (1 Draft / Final Report)
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FDA Emergency on-site Back Office Support 2 days (or 2 days additional Mock Audit)
Training materials includes 10 sets (Additional Sets available):
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Binder Workbooks – 300+ slide workbook
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GMP Handbooks or Medical Device Master Guide - 900+ pages.
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Certificate for each Attendee
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Monthly GMP Training Webinar for new employees.
6 Month Plan - $44,995.00
12 Month Plan - $79,995.00
***CAPA Manager
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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.
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Includes 4 hours of customization per procedure.
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Additional procedures provided for $995 each with 4 hours of customization.
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Additional hourly rate for SME will be billed at $295.00 per hour.
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Quality Management Systems are available for quote. Microsoft Excel spreadsheets are available for free upon contract. Call for details.
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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:
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Audit – On-site 3-day Commencement Audit (With Report)
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Weekly scheduled 4-hour remote CAPA Manager meeting & Gap Analysis updates with Meeting & Gantt Reports.
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Up to 25 – Quality Assurance SOPs (see CAPA Manager)
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3-day SME Document Review and Document Gap Analysis
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Access to Templates on GMP Help Desk
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2-day on-site GXP Training by GMP Boot Camps – 1st Month.
- Quality Assurance Manual or Manual updates
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Up to 6 – Computer Systems & 21 CFR Part 11 SOPs
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GANTT Management and Project Manager – 6-Months***
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Audit – 1-day onsite GMP Audit – 6th Month.
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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):
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Binder Workbooks – 300+ slide workbook
-
GMP Handbooks - 900+ pages.
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Certificate for each Attendee
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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...
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Up to 30 – Procedures (see CAPA Manager)
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Up to 10 – Computer Systems & 21 CFR Part 11 Procedures
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Audit – 2-day on-site GMP Audit – 6th Month.
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Audit – 1-day on-site GMP Audit – 12th Month.
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2-day on-site GXP Training by GMP Boot Camps – 12th Month
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FDA Emergency on-site Back Office Support up to 4-days (or 2 days additional Mock Audit)
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Training Material Sets up to 20 Attendees
Gantt Driven QMS Project Management
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.
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Get your products to the market faster.
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Avoid Company Liability
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Envision Your Return On the Investment (ROI)
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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.
