Instrumentation Calibration Program for the Life Science Industry

Instrumentation Calibration Program for the Life Science Industry

This course reviews the regulatory requirements and methods for determining calibration specifications and relates these methods to validation of critical utilities, manufacturing processes and laboratory testing instruments. Activities in this course include analyzing different types of calibration documents and understanding how these documents are developed and used to ensure completion of validation.

This course may be taught at any location.
Level: Advanced
Lecture Hours: 8.00
Lab Hours: 0.00
Total Contact Hours: 8.00

Request this Course

Request this Course

Submit this form to request this course to be scheduled.

Image CAPTCHA
Enter the characters shown in the image.

Topics Include

This 1 day, 8 hour course, covers the following topics:

  • Historical perspective on calibrations
  • Regulations that apply to instrument calibration programs
  • Benefits of compliant instrumentation calibration programs
  • Critical elements of a calibration program
  • Different types and purpose of calibration documents
  • Calibration Software
  • Effective ways of managing a calibration business
  • Audit of contracted calibration labs
  • Review and approval of calibration deviations, CAPA and change control.
  • Calibration performance metrics
  • Benefits of going to a paperless program

Learning Objectives

Upon successful completion, participants will be able to:

  • Describe important considerations for developing and maintaining  instrumentation calibration  programs
  • Identify the four critical elements of calibration programs
  • Explain the importance of instrumentation calibration programs for ensuring product quality and compliance
  • Describe the components necessary for effectively managing a calibration program

Audience

The course is designed for pharmaceutical professionals with responsibilities in areas of manufacturing, validation, quality assurance, engineering and maintenance.

Related Content

Current Courses
View All
September
30
Introduction to Computer Validation
This course gives an overview of computer validation and its fundamental principles, for both automation and information systems. The course addresses the CGMP requirements related to computer validation, phases/life cycle of computer validation and computer systems, and documentation requirements
November
7
Fundamentals of Validation
This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation. A brief historical overview of regulatory requirements is followed by current requirements, user needs, process design and
December
4
Good Lab Practices: FDA and EPA Regulations
Understand the documentation guidelines required to generate acceptable EPA and FDA product registration safety studies. In this course, you will undertake a series of exercises, including labeling activities, protocol review, and adherence to Standard Operating Procedures to reinforce course
  •  
  • 1 of 3
  • >
Current Courses
View All
August
19
Computer Application Validation
Interactively learn and apply requirements in validating Computer System Applications. By concentrating on information systems and instruction on how to meet requirements of CFR 21, Part 11 Electronic Records, Electronic Signatures, the course includes how to test systems security, data integrity,
September
30
Introduction to Computer Validation
This course gives an overview of computer validation and its fundamental principles, for both automation and information systems. The course addresses the CGMP requirements related to computer validation, phases/life cycle of computer validation and computer systems, and documentation requirements
October
30
Sterilization and Controlled Temperature Environment Validation
This course provides participants with an in-depth understanding of steam sterilization as well as the current methods of validation for sterile processes in the pharma/biotech manufacturing environment, including Autoclaves and Steam in Place (SIP) Systems, by providing a thorough understanding of
  •  
  • 1 of 3
  • >
eLearning
View All
Validation Fundamentals
Validation Fundamentals
In this short eLearning course, you'll learn the fundamentals of process and equipment validation in the manufacture of pharmaceuticals. Explore the history of validation, what validation means, what must be validated, and when it must be validated.
Drug Development Overview
Drug Development Overview
This eLearning module will give you an understanding of the process used to develop drugs and why it costs so much to bring a new drug to your pharmacy.
Regulations and Guidance
Regulations and Guidance
In this eLearning module you will learn about the federal and international regulations that protect human participants in research studies. You will also get to be a drug company auditor, reviewing research studies at clinics to see if the staff are following the regulations, and looking for
  •  
  • 1 of 4
  • >
eLearning
View All
cGMP OSHA
cGMP OSHA
Lesson 3: In this guided exercise, learners will explore environmental protection policies, look at the purpose of and use of Material Safety Data Sheets (MSDS/SDS), and explore how to protect yourself from injury on the job.
cGMP Bloodborne Pathogens
cGMP Bloodborne Pathogens
Lesson 2: Bloodborne Pathogeons explores the fundamentals, transmission methods, and prevention techniques for reducing the risk of exposure. This lesson also details several common types of bloodborne pathogens as well as reviews personal protective equipment, proper response to exposure, and
cGMP Basics
cGMP Basics
Lesson 1: Introduction to Current Good Manufacturing Practices, introduces the fundamentals of cGMP and how they apply to the companies that implement them, the employees that use them, and the customers that benefit from them. At the completion of this training exercise, the learner will be able
  •  
  • 1 of 4
  • >
eLearning
View All
Good Laboratory Practices (GLP)
Good Laboratory Practices (GLP)
You’re the newest member of the Quality Assurance department at CATT - the Center for the Advancement of Toast Technology. Your mission is to audit the company and determine if it’s SOPs, notebooks, equipment, personnel, reagent labels, and test animals are GLP compliant.
Good Manufacturing Practice (GMP) Requirements
Good Manufacturing Practice (GMP) Requirements
GMPs help ensure the quality, safety, and efficacy of a product. You'll explore Good Manufacturing Practices as you work through several interactive scenarios in a virtual manufacturing facility.
Deliberate Documentation
Deliberate Documentation
Hi, I’m Mia! Let's discover how documentation is kept and used in a regulated manufacturing environment. So why is documentation important? Well, think about this situation. You’re preparing a solution that's used as a component in several products manufactured by your company. Many people count on
  •  
  • 1 of 4
  • >
Videos
View All
BioNetwork Capstone Center
Capstone Center
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone, fundamental scientific understanding meets hands-on application.  Our industry-experienced instructors lead courses in bioprocessing, quality control, compliance, cGMP, analytical chemistry, and microbiology
Golden LEAF Biomanufacturing Training and Education Center
Golden LEAF BTEC: Knowledge in Action
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh is home to two top-tier learning organizations: NC State and BioNetwork. Through this unique partnership, learners from a wide range of backgrounds can find the right educational program to meet their career goals, and
NC Life Science
NC Life Science
This video surveys examples of life science-related training provided by NC Community Colleges for local employers, and how that training supports North Carolina's position as a leading life science industry hub. Representatives of tissue-engineering, clinical research, and pharmaceutical
  •  
  • 1 of 4
  • >
Videos
View All
BioNetwork Capstone Center
Capstone Center
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone, fundamental scientific understanding meets hands-on application.  Our industry-experienced instructors lead courses in bioprocessing, quality control, compliance, cGMP, analytical chemistry, and microbiology
Golden LEAF Biomanufacturing Training and Education Center
Golden LEAF BTEC: Knowledge in Action
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh is home to two top-tier learning organizations: NC State and BioNetwork. Through this unique partnership, learners from a wide range of backgrounds can find the right educational program to meet their career goals, and
Bioprocessing Part 3: Purification
Bioprocessing Part 3: Purification
This video is the third in a series of three videos depicting the major stages of industrial-scale fermentation: fermentation, separation/recovery, and purification. This program describes the process by which a biological product—in this case, a pure, concentrated solution of Green Fluorescent
  •  
  • 1 of 4
  • >
Videos
View All
Lab Safety Lesson 1: Proper Dress and PPE
Lab Safety Lesson 1: Proper Dress and PPE
The lab environment is hazardous by nature. The actual risk is largely determined by you and those working with you. It's your responsibility to know and follow the rules and be able to recognize potential safety hazards. The first consideration is proper dress. What you wear in the lab can help
Aseptic Gowning for the Cleanroom
Aseptic Gowning for the Cleanroom
One of the primary safeguards that life science companies use to help prevent contamination in cleanroom operations is Gowning. Gowning is basically putting on clothing -- in this case layers of specially designed garments, covers, masks and gloves -- that isolates your body from the clean room
BioNetwork Capstone Center
Capstone Center
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone, fundamental scientific understanding meets hands-on application.  Our industry-experienced instructors lead courses in bioprocessing, quality control, compliance, cGMP, analytical chemistry, and microbiology
  •  
  • 1 of 4
  • >