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Auditing and Validation Services for FDA Regulated Industry
 
 

Note: Credit card charges may include a transaction fee of 3%.
Credit Cards may also be taken by phone @ 1-856-596-2333.

GXP Audits with Optional Training Boot Camps
Continental US Audits Include: Transportation, Training Materials, Hotels & Expenses.
International Audits
 

Training Boot Camps
US Boot Camps Include: Transportation, Training Materials, Hotels & Expenses.
International Boot Camps Include: Transportation, Training Materials, Hotels & Expenses.
 

Presentations
GMP Boot Camp Presentations
 


Daily Rates

Daily Rates - Auditors - Instructors*
  * Does not include Travel, Expenses and Hotels
Retainers - SME Consultation - Turnkey QMS
Retainer Options

For Existing Customers:
GXP Audit Deposit Options
 
Expedite Charge - Services provided within 45 day required notice

Hourly Rate - Senior Subject Matter Expert Billed out at $195.00 per hour.
(does not include Travel, Hotels, Expenses)

 
 
Turn-Key QMS - GMP Requirements - SOPs and Training Materials
Meeting 21 CFR Requirements and Predicate Rules

Basic Level 1 Turn-Key QMS - $6,595.00***

Includes:

- 16 Hours Zoom Meetings
- 5 Free Seats for the Monthly GMP/QMS Webinar
- 5 Sets Course Materials, Handbooks &Certificates

Turn-Key Documents (Templates)

  • Policy Sample
  • Standard Operating Procedures - SOP/WI
  • Risk Management
  • Corrective and Preventative Actions (CAPA)
  • Non-Conformance
  • Change Control
  • Deviations
  • Complaints Management
  • Recalls and Recall Challenge
  • Internal Audit
  • Vendor Management
  • Document Control Management Practice
  • Good Documentation Practice (GDocP)
  • Annual Product Review
  • Visitor Management
  • Logbook Management
  • Training and Development
  • Receiving - Materials
  • Quarantine - Incoming and Finished Products
  • Rejected Materials
  • Sampling Practice
  • Inventory Control - Cycle Counting and Reconciliation
  • Label Management and Label Control
  • Asset Management
  • Engineering, Maitnenance and Calibration Program
  • Pest Control
  • Gowning Requirements
  • Sanitation and HouseKeeping Practice
  • Qualification and Validation
  • Quality Control Testing
  • 21 CFR Part 11 Compliance
  • Data Backup and Recovery
  • Validation Master Plan
  • Batch Record Management

 

Basic Level 2 Turn-Key QMS - $11,995.00***

Includes:

- 24 Hours Zoom Meetings
- 10 Free Seats for the Monthly GMP/QMS Webinar
- 10 Sets Course Materials, Handbooks &Certificates

Turn-Key Documents (Templates)

  • Quality Manual Template
  • Corporate Risk Statement
  • Validation Master Plan
  • Policy Sample
  • Standard Operating Procedures - SOP/WIs
  • Risk Management
  • Corrective and Preventative Actions (CAPA)
  • Non-Conformance
  • Change Control
  • Deviations
  • Complaints Management
  • Recalls and Recall Challenge
  • Traceability - Product
  • Internal Audit
  • Vendor Management
  • Document Control Management Practice
  • Good Documentation Practice (GDocP)
  • Quality Review
  • Annual Product Review
  • Visitor Management
  • Logbook Management
  • Training and Development
  • GMP Training Curriculum
  • Roles and Responsiblities
  • Hiring Practices
  • Receiving - Materials
  • Quarantine - Incoming and Finished Products
  • Rejected Materials
  • Out of Specification (OOS)
  • Sampling Practice
  • Inventory Control - Cycle Counting and Reconciliation
  • Label Management and Label Control
  • Asset Management
  • Engineering, Maitnenance and Calibration Program
  • Pest Control
  • Gowning Requirements
  • Sanitation and HouseKeeping Practice
  • Qualification and Validation
  • Quality Control
  • 21 CFR Part 11 Compliance
  • Data Backup and Recovery
  • Validation Master Plan
  • Process Validation
  • Equipment Validation
  • Batch Record Management
  • Rework and Reprocessing
  • Signature Logs
  • Retains - Area and Inventory Management
  • Reserves - Area and Inventory Management

Basic Level 3 Turn-Key QMS - $19,995.00***

Includes:

- 40 Hours Zoom Meetings
- 20 Free Seats for the Monthly GMP/QMS Webinar
- 20 Sets Course Materials, Handbooks &Certificates

Turn-Key Documents (Templates)

  • Quality Manual
  • Corporate Risk Statement
  • Validation Master Plan
  • Facility Qualification Plan (FQP)
  • Basis of Design Template
  • Regulatory Affairs
  • Product Safety
  • Policy Sample
  • Standard Operating Procedures - SOP/WI
  • Risk Management
  • Corrective and Preventative Actions (CAPA)
  • Non-Conformance
  • Change Control
  • Deviations
  • Complaints Management
  • Recalls and Recall Challenge
  • Traceability - Product
  • Internal Audit
  • Vendor Management
  • Document Control Management Practice
  • Good Documentation Practice (GDocP)
  • Quality Review
  • Annual Product Review
  • Annual Product Review
  • Visitor Management
  • Logbook Management
  • Training and Development
  • GMP Training Curriculum
  • Roles and Responsiblities
  • Hiring Practices
  • Receiving - Materials
  • Quarantine - Incoming and Finished Products
  • Rejected Materials
  • Out of Specification (OOS)
  • Sampling Practice
  • Inventory Control - Cycle Counting and Reconciliation
  • Label Management and Label Control
  • Retains - Area and Inventory Management
  • Asset Management
  • Engineering, Maitnenance and Calibration Program
  • Pest Control
  • Gowning Requirements
  • Sanitation and HouseKeeping Practice
  • Qualification and Validation
  • Quality Control
  • 21 CFR Part 11 Compliance
  • Data Backup and Recovery
  • Validation Master Plan
  • Process Validation
  • Equipment Validation
  • Batch Record Management
  • Rework and Reprocessing
  • Signature Logs
  • Retains - Area and Inventory Management
  • Reserves - Area and Inventory Management
  • FIFO - First In - First Out Management
  • Waste - Area and Inventory Management
  • Environmental, Safety and Health

***Please Note:

  1. All Procedures requires Client configuration for implementation. TAG will not be responsible for completion or accuracy of procedures as additional configuration is required by Client.
  2. All drafts of Documentation will maintain 'Track-Changes' for history purpose untill final approval by Client.
  3. All approvals will be signed off by the Client as final and accepted.
  4. Additional Man-hours can be purchased here
 
Extra Sets - Binders, Books, Certificates and Shipping

By Bank Wire - Please see invoice for banking instructions

By Check - Make all checks payable to: The Auditing Group, Inc.

Physical Address: (for FedEx) PO Box (for regular mail)
The Auditing Group, Inc.
4 Linda Lane, Suite B
Southampton, NJ 08088
The Auditing Group, Inc.
P.O. 1696
Medford, NJ 08055

If you have any questions, please feel free to call 001-856-437-5880

 

 

 

 

 

 

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GMP - Good Manufacturing Practice Audit

GCP - Clinical Audits - Regulatory Audits

Equipment Validation Documentation Audit

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Part 11 / Annex 11 Compliance

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CMOs, Laboratories, API Manufacturers

CROs, Investigators, Monitors, and Study Sites

Database Audits, SAS, CMMS, eDC, eCFR, Safety

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Training Services

Template Implementation

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Development Part 11 Initiatives

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Certified AIA 'As-Built' Drafting Services

Process and Equipment Validation Services

Software and Systems Validation Services

Design / Build Engineering Services
 

 


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