Downloads for Ideal Knowledge Transfer
Pharmaceuticals

Pharmaceuticals

Computer System Validation Procedures and Templates Suite
This package features 29 procedures and templates which provide a foundation for implementing a comprehensive Computer System Validation program within an organization.
$899.00
Introduction to cGMP Current Good Manufacturing Practices Training Package
This training package features an Adobe Flash training presentation with audio, which provides a strong tool for training a workforce in the fundamentals of cGMP manufacturing.
$299.00
Introduction to cGDP Current Good Documentation Practices Training Package
This training package features an Adobe Flash training presentation with audio, which provides a strong tool for training a workforce in the fundamentals of current Good Documentation Practices.
$199.00
Universal IQ / OQ Protocol Template Package
This template package features a universal IQ/OQ Protocol template that provides a ready-to-populate document to generate an IQ, OQ, or IOQ in the pharma or biotech industry.
$199.00
Universal Technology Transfer Template Pack 1
This template package contains our most popular Technology Transfer templates.
$629.00
Leveraging Statistics for Validation Training Package
This training package features a training presentation which provides an overview of statistical methods and how they can be utilized for validation.
$99.00
Project Management Tools: Project Charters Training Package
This training package features a training presentation, which provides background and supplemental information on using Project Charters, and a Project Charter template.
$99.00
Riboflavin Coverage Test SOP Template Package
This SOP package features an SOP template that provides instructions for the preparation and execution of riboflavin coverage tests in washers and tanks.
$149.00
Audit Preparation Checklist Template Package
This package features a universal audit / inspection preparation checklist template which provides a comprehensive list of tasks and activities that should be performed by multiple departments in preparation for a regulatory inspection or audit.
$99.00
Change Management Form Template for Project Management
This template package features a universal Change Management Form Template that provides a method for formally tracking and approving changes in a project which are outside of the approved project charter or project plan.
$9.99
Communication Plan Template Package
This template package features a universal Communication Plan Template that provides a method for clearly defining the communication responsibilities, rules, vehicles, and frequency for any project.
$49.00
Kickoff Meeting Agenda Template Package
This template package features three universal Kickoff Meeting Agenda Templates that provide the tools to effectively facilitate and manage a 2 hour, 4 hour, or 8 hour long Kickoff Meeting for any project.
$49.00
Project Closeout Form Template
This template package features a universal Project Closeout Form Template that provides a method for formally closing out a project, including performing a Lessons Learned, Risk Plan review, and project file archival.
$9.99
RACI Diagram Template Package
This template package features a universal RACI Diagram Template that provides a method for clearly communicating roles and responsibilities on a team during any project.
$9.99
Risk Management Process Template Package
This package features a standard procedure which outlines the approach for managing risk within any project. Three universal templates to support the creation of a plan for managing risks are also provided.
$99.00
Stakeholder Analysis Template Package
This template package features a universal Stakeholder Analysis Template that can be used to outline those individuals and/or organizations who may impact or be impacted by a project.
$9.99
Aseptic Gowning & Cleanroom Behaviors Training Package
This package features a training presentation that outlines a standard procedure for aseptic gowning, as well as recommended cleanroom behavior for aseptic processing areas.
$199.00
CAPA Information and Guidelines Training Package
This training package features a comprehensive introduction to the CAPA (Corrective Action and Preventive Action) process.
$149.00
Introduction to Automated Inline Dilution Technical Presentation Package
This package features a technical presentation which provides an overview of Automated Inline Dilution processes and equipment.
$99.00
Process Water Coolers Technical Presentation Package
This training package features a technical presentation which provides a comprehensive introduction to process water coolers.
$99.00
Data Logging Technical Presentation Package
This training package features a technical presentation which provides a comprehensive overview of data logging in FDA regulated industries.
$99.00
Refrigerator Thermal Mapping SOP Package
This SOP package features an SOP template that provides a step-by-step procedure and test logs for thermal mapping a pharmaceutical refrigerator.
$49.00
Meeting Agenda & Meeting Minutes Template Package
This template package features two universal meeting agenda and meeting minutes templates that can be used to effectively facilitate and manage any meeting.
$49.00
Action Item List & Decision Register Template Package
This template package features a universal action item list and decision register template that can be used to easily manage tasks and responsibility for any project or meeting.
$49.00
Analytical Assay Summary Template Package
This template package features a universal Analytical Assay Summary template that can be used to provide the most up-to-date information on all assays used for in-process testing, lot release, characterization, raw material testing, and other assays related to a specific process requiring technology transfer.
$49.00
Introduction to Microbiology & Aseptic Processing Training Package
This training package features a training presentation which provides background information on microbiology and an overview of aseptic processing in GMP facilities.
$99.00
Analytical Balance SOP Template Package
This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of micro and ultra-micro analytical balances.
$49.00
The Art of Sales Training Package
This training package features a training presentation which provides tips and techniques on the art of sales.
$49.00
Bill of Materials Template Package
This template package features a universal Bill of Materials template that can be used to provide the most complete information on all components, raw materials, consumables, reagents, and biologic materials.
$9.99
Biologic Material Transfer Log Template Package
This template package features a universal Biologic Material Transfer Log template that can be used to document the transfer of cells and intermediates in various stages of processing, including purified product and reference standard. The log provides basic information on the origin, nature, and key biological and safety properties of the materials in question.
$9.99
Biological Safety Cabinets (BSC) SOP Template Package
This SOP package features an SOP template that provides instructions for pre-use cleaning and disinfection, operation, and post cleaning for a Class II, Type B2 biological safety cabinet.
$49.00
Certificate of Translation Template Package
This template package features a universal Certificate of Translation template that can be used to properly document and certify any documents that require translation.
$9.99
cGMP Documentation System SOP Package
This SOP package features a standard procedure that defines a fully compliant GMP documentation system for any GMP facility.
$99.00
cGMP Training System SOP Package
This SOP package features a standard procedure outlining a completely defined and cGMP compliant training system.
$99.00
Change Management Template for Tech Transfer
This template package features a universal Change Management template that can be used to provide information on both contemplated and actual modifications to the process and/or its components in a controlled and documented manner.
$9.99
Cleaning Validation for Pharma & Biotech Training Package
This training package features a training presentation which provides an overview of cleaning validation in the pharmaceutical and biotech industries.
$199.00
Data Recording Standards SOP Package
This SOP package features a standard step-by-step procedure for handling numerical raw data and calculations.
$49.00
Equipment List Template Package
This template package features a universal Equipment List template that can be used to provide the most complete information on all critical and auxiliary systems for the transferred manufacturing process and associated testing.
$9.99
Feed Through Assembly Construction & Operation SOP Package
This SOP package features a comprehensive step-by-step procedure that provides instructions for the construction, installation, and operation of a feed through assembly.
$49.00
Feed Through Assembly Equipment Package (For Purchase)
The Kymanox Feed Through Assembly is a cost effective method for inserting thermocouples into pressurized environmental chambers, such as sterilizers.
$299.00
Feed Through Assembly Equipment Package (For Rental)
This rental package provides a cost effective method for inserting thermocouples into pressurized environmental chambers, such as sterilizers.
Interview Evaluation Template Package
This template package features a universal Interview Evaluation template that can be used to conduct and rate any interview for potential employment.
$9.99
Introduction to Cell Culture Training Package
This training package features a training presentation that provides an overview of cell culture processes and terminology, including cell culture vs. fermentation, cell lines, manual & automated cell culture, harvest, and cell banking.
$99.00
Introduction to Validation Master Plans (VMP) Training Package
This training package features a training presentation which provides training and quality professionals with a strong tool for training their workforce in the basics of validation master plans.
$99.00
Kaye Validator 2000 Best Practices SOP Package
This SOP package features an SOP template that includes detailed instructions for the setup and operation of a PC-controlled, Kaye Validator 2000 system that are not available in the GE Sensing procedures.
$49.00
Kaye Validator 2000 Equipment Package (For Purchase)
This equipment package includes everything needed to perform reliable, highly accurate temperature studies, including a laptop PC and 36 premium thermocouples.
$20,000.00
Kaye Validator 2000 Equipment Package (For Rental)
This equipment rental package includes everything needed to perform reliable, highly accurate temperature studies, including a laptop PC, feed through assembly, and 36 premium thermocouples.
$1,500.00
Kaye Validator 2000 Services
Kymanox provides experienced personnel to perform data logging services using the Kaye Validator 2000 to deliver the information that you need.
Material Receipt & Lot Testing Template Package
This template package features a universal material receipt and lot testing template that can be used for receiving raw materials and executing incoming testing.
$9.99
Material Specification SOP Template Package
This SOP package features an SOP template that outlines the procedure for releasing incoming raw materials. A Material Receipt & Lot Testing template form is also provided.
$99.00
Meeting Facilitation SOP Package
This SOP package features a procedure for effectively planning and facilitating any meeting. Three universal templates to support meeting facilitation are also provided.
$149.00
pH & Conductivity Meter SOP Template Package
This SOP package features an SOP template that provides instructions for the setup, calibration, and operation of a pH/Conductivity Meter.
$49.00
Pharmaceutical Freezer SOP Template Package
This SOP package feactures an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical freezer.
$49.00
Pharmaceutical Incubator SOP Template Package
This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical incubator.
$49.00
Pharmaceutical Refrigerator SOP Template Package
This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical refrigerator.
$49.00
Pharmaceutical Ultra-Freezer SOP Template Package
This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical ultra-freezer.
$49.00
Post Validation Monitoring Training Package
This training package features a training presentation which provides training and quality professionals with a strong tool for training their workforce in the basics of post validation monitoring and validation lifecycle management.
$99.00
Principles of Validation Training Package
This training package features a training presentation that provides an overview of validation and discusses the need for validation, the validation process, and what it means to operate in a state of control.
$99.00
Project Charter Template Package
This template package features a universal Project Charter template with example text that can be used for any project requiring a Project Charter.
$49.00
Project Management Fundamentals Training Package
This training package features a training presentation which provides a strong introduction and detailed overview to the fundamentals of project management.
$99.00
Project Roster Template Package
This template package features a universal project roster template that includes all of the pertinent information that should be captured in any project roster.
$9.99
Purification: Principles & Techniques Training Package
This training package features a training presentation which provides an overview of purification processes and terminology.
$99.00
Quality Plan Template Package
This template package features a universal Quality Plan template with example text that can be integrated into any documentation system and used to define the quality practices, resources, and activities relevant to a process.
$99.00
Sampling Plan Template Package
This template package features a universal Sampling Plan template that can be used to provide information on quantity, size, and nature of samples of materials to be collected at various stages or unit operations for process control, release, or informational purposes. This template is especially useful for technology transfers.
$9.99
SmartReader Data Logger SOP Template Package
This SOP package features an SOP template that provides instructions for the setup and operation of SmartReader data loggers from ACR Systems.
$49.00
Solution Formulation Template Package
This template package features a universal Solution Formulation template that can be used to outline the minimum requirements for the successful transfer of information necessary for the preparation of buffers, media, and other solutions.
$49.00
SOP Template Package
This template package features a universal SOP template that can be integrated into any documentation system and used for formatting any policy, process, or procedure document.
$49.00
SOP Writing Procedure Package
This SOP package features a procedure that provides comprehensive instructions on creating comprehensive, effective, and clear Standard Operating Procedures in any industry.
$99.00
Traceability Matrix Template Package
This template package features a universal traceability matrix template that provides a ready-to-populate document and spreadsheet to generate a trace matrix for any system validation.
$49.00
Training Attendance Sheet Template Package
This template package features a universal Training Attendance Sheet template that can be used to properly track and document the attendees of any training course.
$9.99
Universal Technology Transfer Checklist Package
This Standard Operating Procedure (SOP) package features a 19 page document which outlines guidelines for transferrring technology for the development or manufacturing of biopharmaceuticals, vaccines, or combination devices.
$49.00
Universal Technology Transfer SOP
This Standard Operating Procedure (SOP) package features a 19 page document which outlines guidelines for transferrring technology for the development or manufacturing of biopharmaceuticals, vaccines, or combination devices.
$99.00
User Requirements Specification Template Package
This template package features a comprehensive outline of the information required in a User Requirements Specification for the Biotechnology, Medical Device or Pharmaceutical industries. It includes sections for process overview, design and construction, operational requirements, automation requirements, safety, acceptance and delivery, and documentation. Suggested technical content is also included throughout the template.
$99.00
Weighted Grid Analysis Tool Package
This package features a universal Weighted Grid Analysis Tool that provides a method for comparing multiple project options.
$9.99
Workplace Harassment Training Package
This training package features a training presentation which provides basic training for managers and employees on workplace harassment.
$9.99
Writing Assay Transfer Plans Package
This SOP package features a procedure that provides comprehensive instructions on creating Assay Transfer Plans, which provide information on assays requiring transfer, activities related to assay qualification at the receiver site, as well as expected results and specifications.
$49.00
Writing Assay Transfer Reports Package
This SOP package features a procedure that provides comprehensive instructions on creating Assay Transfer Reports, which provide documented proof that transferred assays perform at the receiver's facility and in the receiver's hands acceptably and comparably with the sender.
$49.00
Writing Detailed Process Descriptions Package
This SOP package features a procedure that provides comprehensive instructions on creating Detailed Process Descriptions, which provide the most up-to-date information on equipment, materials, methods, process steps, and unit operations, as well as specifications for raw materials and components, intermediates, bulk drug substances, and drug product.
$99.00
Writing Experiment Reports Package
This SOP package features a procedure that provides comprehensive instructions on creating Experiment Reports, which document the details of an individual experiment or trial performed as part of a process transfer.
$49.00
Writing Process Transfer Plans Package
This SOP package features a procedure that provides comprehensive instructions on creating Process Transfer Plans, which outline, in detail, the strategies, activities, and timeline for transferring a process between different facilities, as well as provide expected results and specifications for the transfer.
$49.00
Writing Process Transfer Reports Package
This SOP package features a procedure that provides comprehensive instructions on creating Process Transfer Reports, which provide documented proof that a transferred process performs at the receiverís facility and in the receiverís hands acceptably and comparably with the sender.
$49.00
Writing SOPs Training Package
This training package features a training presentation which provides basic training for employees responsible for writing or managing SOP documents.
$99.00
Writing Validation Protocols Training Package
This training package features a training presentation which provides basic information on the writing and execution of validation protocols.
$99.00
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