IVT Active Product List

Toolkits and Compiled Sets

GMP Compliance Toolkit - BNDQ0004  

Member: $895.00/Non-member: $995.00

This product toolkit will guarantee regulatory compliance with FDA and global regulatory agencies. Consisting of two special editions, two pre-recorded webinars, and a specialized IVT conference compendium, this product collection covers GMP Training, investigations and inspections, documentation, quality agreements, HACCP, and utilizing statistics.        

Products in this Toolkit

Analytical Method Validation Toolkit - BNDQ0005

Member: $895.00/Non-member: $995.00

This toolkit highlights the most comprehensive information on analytical method validation and method development. With four robust volumes of thought leadership from the Journal of Validation Technology and the Journal of GXP Compliance, and thousands of slides from IVT's Laboratory Week conferences, this educational toolkit will ensure you keep abreast of ongoing method strategies and global regulatory trends.             

Products in this Toolkit

CSV Toolkit - BNDQ0006

Member: $499.00/ Non-member: $595.00

This collection of IVT Computer and Software Validation Products will guarantee compliance in the ever-changing and evolving CSV environment. With two eBooks, conference compendia, and master plans, this toolkit offers strategies for electronic records and signatures management, the emergence of cloud computing and virtualized environments, international regulations and guidances, risk management and change control integration, automated testing tools, building software, data integrity.                 

Products in this Toolkit

Process Validation Toolkit - BNDQ007

Member: $495.00/Non-member: $495.00

A collection of IVT's knowledge of process validation, this toolkit is composed of two years of Validation Week presentations, the Process Validation Lifecycle e-Book Series, a recorded validation seminar, a sampling instruction and a process validation whitepaper, and two validation master plans. These materials will guide process validation practitioners in effectively implementing a lifecycle approach to process validation and, thereby, achieving compliance with global regulatory agencies.           

Products in this Toolkit

Analytical Method Validation Vol. I-IV - The Complete Collection - BNDQ008

Member: $376.00 / Non-member: $595.00

This four-volume, 265-page set from the Institute of Validation Technology offers detailed discussions on achieving compliant analytical method validation as well as specific case studies that demonstrate best practices. This is a downloadable PDF product — start applying its lessons immediately!    

Products in this Toolkit

Cleaning Validation Toolkit - BNDQ009

Member: $199.00/Non-member: $299.00

Cleaning remains the backbone of validation and scholarship, practices, and regulations continue to change, adapting to new technologies and markets. Gathered from the best and most recent cleaning articles from The Journal of Validation Technology and The Journal of GXP Compliance, IVT Network presents a compilation of their multi-volume books series. 

Products in this Toolkit

Pharmaceutical Microbiology Toolkit - BNDQ010

Member: $550.00/Non-member: $700.00

Some of the finest in pharmaceutical microbiology thought leadership is found in this comprehensive new toolkit. This toolkit features: Essential Microbiology for GXP Compliance, a test protocol to assist with low endotoxin recovery, and the past two compendia from our annual Microbiology Week events (40 presentations total!). Purchasing this toolkit unlocks all of these tools at a discount. 

Products in this Toolkit

Medical Device Validation Toolkit - BNDQ011

Member: $595.00/Non-member: $595.00

The Medical Device Validation Bundle has all you need to be prepared for your next device inspection, with our best selling products sold together at a deep discount. Valued at $1,085, this bundle provides big savings across the board - especially when you are prepared to implement medical device best practices.  

Products in this Toolkit

Quality Risk Management Toolkit - BNDQ013

Member: $695.00/Non-member: $895.00         

This bundle is packed with tools, tips and tactics on risk management and developing a risk-based approach to quality systems. From risk analysis to risk management strategies, to creating a risk aware culture, and prioritizing cGMP Inspections of pharmaceutical manufacturing sites, these articles, presentations and podcasts covering the topic will provide today's regulations, and the industry's most progressive best practices. 

SOPs & Templates

ALCOA for Data Integrity 
Member: $60.00/Non-member: $80.00               

Auditor's Pocket Checklist for Pharmaceutical Water
Member: $175.00/Non-member: $195.00

CAPA SOP Template      
Member: $175.00/Non-member: $195.00

cGMP Computerized System Vendor Audit Questionnaire  
Member: $175.00/Non-member: $195.00

Change Control Guide Questions             
Member: $175.00/Non-member: $195.00

Change Control Management SOP          
Member: $175.00/Non-member: $195.00

Computerized System Change Control Impact Assessment Template              
Member: $175.00/Non-member: $195.00

Configuration Management Plan Template       
Member: $250.00/Non-member: $250.00

Data Integrity Checklist and Worksheet
Member: $175.00/Non-member: $195.00

Document Control systems SOP              
Member: $175.00/Non-member: $195.00

Environmental Control SOP and Audit                  
Member: $175.00/Non-member: $195.00

Environmental Monitoring HAACP          
Member: $175.00/Non-member: $195.00

Equipment Systems and Validation         
Member Only

Equipment Vendor Quality Questionnaire           
Member: $175.00/Non-member: $195.00

Gap Analysis Checklist   
Member Only

Internal Audit Quality Checklist               
Member: $175.00/Non-member: $195.00

Key Validation Elements for Automated Processes          
Member: Free/Non-member: Free

Lab Change Control Checklist     
Member: Free/Non-member: Free

Method Validation  and Transfer Documentation            
Member: Free/Non-member: Free

Method Validation Reports and Protocol             
Member Only

New Product Stability                  
Member: $175.00/Non-member: $195.00

New Product Stability Checklist for Medical Devices        
Member Only

Procedure for Design Review                   
Member Only

Process Validation Strategy Templates   
Member Only

Quality Agreement and Change Control Report Templates           
Member Only

Revalidation Assessment            
Member Only

Sterile Production Audit and Gap Analysis Materials        
Member Only

Supplier Qualification SOP          
Member: $175.00/Non-member: $200.00 David Stephon 

Supplier Quality Audit Questionnaire and Checklist         
Member: $175.00/Non-member: $195.00                            

Test Script Template     
Member: $175.00/Non-member: $195.00 template

Training Outline Template       
Member: $175.00/Non-member: $195.00

Training Program Assessment Checklist               
Member: $175.00/Non-member: $195.00          

Validation Master Plan and Deliverables             
Member Only

Validation Master Plan Template/Process Validation     
Member: Free/Non-member: Free

Validation Training Facilitation Checklist and Speaking Self-Assessment             
Member Only

Validation Master Plans

Environmental Control Master Validation Plan   
Member: $175.00/Non-member: $195.00

Example of a Biotech Process Validation    
Member Only

Example Validation Master Plan            
Member Only: $995.00

Site Validation Master Plan        
Member Only: $995.00

Site Validation Master Plan II 
Member Only

Validation Master Plan for US Manufacturer 
Member Only

Validation Plan for Heating, Ventilation and Air 
Member Only

VMP Outlines   
Member: $20.00/Non-member: $40.00

Protocols

Determination of Total Organic Carbon Protocol              
Member Only

Determination of Triethylamine (TEA)    
Member Only

HVAC Installation Qualification Protocol
Member Only

HVAC Operation Qualification Protocol 
Member: $80.00/Non-member: $99.00

Installation Qualification Protocol
Member: $175.00/Non-member: $195.00

Low Endotoxin Recovery (LER) Test Protocol
Member: $35.00/$50.00

Special Editions

Analytical Method Validation
Member: $175.50/Non-member: $195.00

Analytical Method Validation Volume II
Member: $175.50/Non-member: $195.00

Analytical Method Validation Volume III
Member: $175.50/Non-member: $195.00

Analytical Method Validation Volume IV
Member: $175.50/Non-member: $195.00

Change Control Implementation
Member: $175.50/Non-member: $195.00

Cleaning Validation Vol III
Member: $85.00/Non-member: $99.00

Cleaning Validation Volume IV
Member: $85.00/Non-member: $125.00

Computer and Software Validation
Member: $175.50/Non-member: $195.00

Computer and Software Validation Volume II
Member: $175.50/Non-member: $195.00

Conducting Audits
Member: $175.50/Non-member: $195.00

Conducting Audits, Gap Assessments, & Corrective Actions
Member: $175.50/Non-member: $195.00

Conducting Audits, Gap Assessments, & Corrective Actions Vol II
Members Only

Continuing Process Verification
Member: $175.50/Non-member: $195.00

Corrective and Preventive Action
Member: $175.50/Non-member: $195.00

Corrective and Preventive Action Volume II
Member: $175.50/Non-member: $195.00

Environmental Monitoring Handbook
Member: $89.50/Non-member: $99.00

Equipment and Instrumentation Qualification
Member: $175.50/Non-member: $195.00

Essential Microbiology for GXP Compliance
Member: $175.50/Non-member: $195.00

Facility Qualification
Member: $150.50/Non-member: $195.00

Handbook to Laboratory Best Practices
Member: $89.50/Non-member: $99.00

Process Design
Member: $175.50/Non-member: $195.00

Process Qualification
Member: $175.50/Non-member: $195.00

Roadmap to GMP Compliance Part I
Member: $265.50/Non-member: $295.00

Roadmap to GMP Compliance Part II
Member: $175.50/Non-member: $195.00

Statistics in Validation
Member: $179.00/Non-member $179.99

Test Method Validation for Medical Devices
Member: $80.00/Non-member: $100.00

The ADDIE Model: An Instructional Generic Design Model
Member: $89.50/Non-member: $99.00

The Medical Device Validation Handbook
Member: $175.00/Non-member: $195.00

Utility Qualification
Member: $175.50/Non-member: $195.00

Conference Compendia

Compounding Pharmacy Compliance 2021
Member: $695.00 /Non-Member $895.00

Compounding Pharmacy - Essential Pack
Member: $245.00/Non-member $395.00

Compounding Pharmacy-Regulatory Pack
Member: $245.00/Non-member $395.00

Compounding Pharmacy - Management Pack
Member: $245.00/Non-member $395.00

Compounding Pharmacy – Lab Pack
Member: $354.00/Non-Member $495.00

Computer Systems Validation and Software Assurance Week 2021
Member: $395.00/Non-member $495.00

7th Annual Laboratory Week
Member: $395.00/Non-member: $495.00

6th Annual Laboratory Week
Member: $175.00/Non-member: $195.00

21st  Annual IT and Computerized Systems Validation Week
Member: $395.00/Non-member: $495.00

20th Annual Computer and IT Systems Validation Week
Member: $195.00/Non-member: $295.00

26th Annual Validation Week
Member: $395.00/Non-member: $495.00

24th Annual Validation Week  
Member: $295.00/Non-member: $495.00

10th  Annual Validation Week Europe
Member: $75.00/Non-member: $95.00

Cleaning Validation Summit
Member: $195.00/Non-member: $295.00

Cloud Computing Summit
Member: $195.00/Non-member: $295.00

Data Integrity Validation
Member: $195.00/Non-member: $295.00

Recalls, Returns and Removals
Member: $195.00/Non-member: $295.00

Taking Control of Change, CAPA and COVID - Webinar Replay with Slides
Member: $195.00/Non-member: $295.00

Data Integrity Mock Inspection - Mitigating Risk (Session)
Member: $95.00/Non-member: $195.00

4th  Annual Medical Device Validation Week
Member: $175.00/Non-member: $195.00

4th  Annual Data Integrity Validation
Member: $175.00/Non-member: $195.00

3rd  Annual Data Integrity Validation
Member: $75.00/Non-member: $95.00

12th Life Science Forum on Manufacturing Execution Systems (MES) 2017
Member: $95.00/Non-member $195.00

13th Annual Product Recalls Summit  
Member: $75.00/Non-member: $125.00

Laboratory Data Integrity
Member: $75.00/Non-member: $95.00

8th Annual Stability Testing
Member: $75.00/Non-member: $95.00

Quality Risk Management & Change Control  
Member: $195.00/Non-member: $295.00

3rd Annual Medical Device Validation Week
Member: $195.00/Non-member: $295.00

9th Annual Validation Week Europe
Member: $195.00/Non-member: $295.00

19th Annual Computer & Software Validation
Member: $195.00/Non-member: $295.00

6th Annual Microbiology Week
Member: $75.00/Non-member: $95.00

16th Annual Product Complaints Congress for Life Sciences  
Member: $175.00/Non-member: $195.00

Manufacturing Execution Systems 2018
Member: $175.00/Non-member: $195.00

DOWNLOAD PRINTABLE LIST

Validated Cloud logo