GMP, cGMP, and FDA Survival Kits

Survival Kit for Regulatory Inspections

Having the FDA or other regulatory agency arrive to conduct an inspection can be stressful, even terrifying! Being caught off-guard can lead to severe consequences.

BE PREPARED FOR YOUR NEXT FDA INSPECTION

Our Survival Kit for Regulatory Inspections is the answer. Designed to help you develop an Action Plan so that you're totally prepared for your next inspection.

The value of this package is over $2,000 - Now available for only $797!

Here's what you get in the kit:

• Three-hour seminar (on CD or MP3) conducted by David Inglis, Ph.D. Click here to read the full description of the three one-hour segments and Dr. Inglis' qualifications.
• Handouts for the seminar (over 100 slides)
• Checklist of Typical Documents required for FDA Systems-based Inspections
• General Preparation Matrix Plan
• CAPA form and Audit Action Tracker spreadsheet - Investigation and Correction of Quality Incidents/Nonconformities (CAPA - Corrective and Preventive Action)

Questions about this new and exciting product? Call us at 714-289-1233.

Validation Survival Kit

Validation can be a daunting undertaking! Our Validation Survival Kit makes it manageable.

BE PREPARED FOR YOUR NEXT VALIDATION PROJECT

The value of this package is over $2,700 - Now available for only $1097!

Here's what you get in the kit:

• Four-hour seminar (on CD or MP3) conducted by Gamal Amer, Ph.D. Click here to read the full description of the four one-hour segments and Dr. Amer's qualifications.
• Handouts for the seminar (over 125 slides)
• Checklist for Process Validation
• Computer Documentation Collection Checklist
• Deviation Resolution Decision Tree
• Documentation Storage and Retrieval System (Tracking System)
• Documentation Tracking Pages
• Equipment Documentation Collection Checklist
• Validation FAQs
• Guidelines for Process Validation
• Guidelines for SUPAC (Scale-up and Post Approval Changes)
• Installation Qualification Template (IQ)
• Operation Qualification Template (OQ)
• Performance Qualification Template (PQ)
• SOP Template
• SOP Equipment Template
• Validation Master Plan Template (VMP)
• Where and How to Find Information for Establishing Protocol Acceptance Criteria
• Guide to Selecting and Engaging the Services of a Validation Consultant

Questions about this new and exciting product? Call us at 714-289-1233.