Cleaning Validation

USD $35.00

Course duration: Allow 2 to 4 hours to complete this course.

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Description

What is Cleaning Validation in view of GMP compliance measures?

Cleaning validation (definition): Cleaning validation is a procedure for gathering & documenting evidence that cleaning processes (for pharmaceutical manufacturing equipment) will prevent product contamination/cross-contamination. Compliance with GMP Cleaning Validation requirements means “collecting documented evidence that an approved cleaning procedure will reproducibly remove the previous product or cleaning agents used in the equipment below the scientifically set maximum allowable carryover level.” (TGA)

Cleaning validation GMP requirements

Gaps in cleaning validation are often cited in GMP compliance inspections, including failure to validate cleaning materials.

To learn more about Cleaning Validation GMP requirements, including visual inspections, we offer a fully-online course to help you learn the GMP requirements and validation regulations for cleaning processes, procedures & cleaning materials.

This online Cleaning Validation (GMP) training course provides an introductory, yet comprehensive overview of GMP cleaning validation requirements that are crucial for ensuring an effective Pharmaceutical Quality System (PQS).

This Cleaning Validation GMP compliance training course is available in an online format. It includes a fully online Final Assessment that provides the learner with a GMP Certificate of Completion for the GMP training topic (for GMP training program files/personnel training records).

  • This course is an excellent induction course for cleaning validation personnel and others who are involved with risk management and cross-contamination prevention
  • Suitable for anyone working in (or exploring job openings) in the GMP manufacturing sector
  • A must-complete GMP education topic for anyone working in equipment maintenance, cleaning, production, operations, batch releae, and quality control
  • You do not have to complete this Cleaning Validation course in one sitting as you will have access to the course content for 12 months from the date of purchase

Cleaning Validation GMP Compliance – Training Course

Online training format – Course duration: 2 to 4 hours

Cleaning Validation GMP Course - training Cleaning Validation course

What you will learn in this GMP certificate course covering Cleaning Validation requirements

This Cleaning Validation course (GMP compliance training module for the pharmaceutical manufacturing industry) introduces:

  • The principles of contamination controls and how they impact pharmaceutical cleaning systems
  • Specific regulations that apply to cleaning validation processes
  • Visual inspections and “visually clean” (potential contamination issues)
  • Equipment designs that support effective cleaning measures and Cleaning Validation processes
  • Importance of appropriate cleaning product selection
  • Cleaning validation strategies that ensure cleaning processes are performing as intended
  • The importance of a risk management approach and a robust Quality Management System (QMS) and how Cleaning Validation
  • Why Cleaning Validation is such a crucial component of GMP compliance activities and Pharmaceutical Quality Systems (PQS)
  • Cleaning Validation audits – common gaps and audit findings related to cleaning validation issues

Who should take the Cleaning Validation (GMP) training course?

  • Cleaning personnel and contractors including independent suppliers of cleaning services for medical manufacturing industries, pharmaceutical product warehouses, and more
  • Engineers designing cleanrooms
  • Equipment purchasers and qualification/validation personnel
  • Quality Assurance personnel
  • Quality Control personnel
  • Operations and Manufacturing personnel
  • Qualification & Validation personnel
  • Engineering and Automation personnel
  • Anyone within the GMP industry interested in learning about or improving their knowledge of GMP and Validation requirements
  • Job seekers seeking employment in the Pharmaceutical industry
  • Life Science Graduates and Laboratory Personnel

Training course duration: Allow 2 to 4 hours (or longer) to complete this Cleaning Validation course online (internet access required). The completion time for the Cleaning Validation Course module, including the online Cleaning Validation Course Assessment, will depend on numerous factors. These factors include your prior experience and knowledge in relation to GMP manufacturing and Quality Management strategies/risk management; your familiarity with validation processes, your aptitude and learning style, and your ability to devote several hours of your time to complete the Cleaning Validation course module and online Assessment.

These learning factors can vary significantly from learner to learner; but on average, allow 2 to 4 hours to complete this Cleaning Validation Course.

This online Cleaning Validation (GMP) course is available 24/7 from the date of purchase.

One licence per user.

Check your email folders upon ordering for your course login details. Search for the words “cleaning validation” or “login”. 

  • This Cleaning Validation course assumes the learner has at least a basic knowledge of GMP compliance and industry regulations (GMP01, GMP02, Good Recordkeeping are highly recommended for any new employees).
  • This training course is suitable for experienced personnel as well as new graduates or new contractors and cleaning suppliers to the pharmaceutical and manufacturing industries.
This Cleaning Validation GMP compliance training course is for EDUCATION PURPOSES only.

Disclaimer: This Cleaning Validation course does not provide any form of systems design advice or PQS management advice. These online GMP courses should never be used for industry decision-making or management decisions in relation to quality systems of validation processes. These courses are simply educational resources to be used by employees, contractors and suppliers working in the areas of the pharmaceutical industry and/or Cleaning Validation within these sectors.

These courses may other professionals working in roles that could impact product quality, product safety, cross-contamination risks, and/or risk management outcomes during manufacturing processes (as well as in packaging, product storage, transportation and distribution).

This Cleaning Validation (GMP education topic) is recommended to be completed as part of a supervised, comprehensive blended learning experience that includes specific training in relation to the products being manufactured at the production site.

It can be taken alone or in combination with other GMP compliance modules including the Pharmaceutical Manufacturing Fundamentals (PMF) series.

This is, however, a stand-alone course that will benefit anyone who wants to improve their industry knowledge levels; although it is most suited for individuals who already have an understanding of Regulatory Compliance requirements in the following industries. Those industries include but are not limited to: pharmaceuticals, medical devices, blood and tissue products/biological medicines, and/or veterinary medicines manufacturing sectors.

  • Cleaning Validation training courses are imperative for personnel and contractors working in the sectors listed above
  • Adequate training and implementation of Cleaning Validation processes is an important part of an effective Pharmaceutical Quality System (PQS)
  • Gaps in Cleaning Validation and GMP processing equipment cleaning procedures are frequently cited in Audit findings and CAPA investigations

NOTE: If you have numerous employees to train or want to take multiple courses, investigate our training bundles (combining several online industry GMP certificate courses and/or industry orientation courses for a discount).

How much time will I have to complete the Cleaning Validation GMP course after I purchase the course online?

You’ll have 12 months from the date of purchase to review the course materials and take the Final Assessment.

  • The training course remains available to you for 12 months from the date of purchase
  • One user / one licence per purchase and one GMP Certificate of Completion per Course
  • The GMP Compliance Certificate of Completion for the Cleaning Validation (GMP) online training course is downloadable and printable
  • It requires you to successfully complete an online Final Assessment, offered at the end of the online training module.

Other courses that will benefit learners include Good Recordkeeping Practice, GxP, and the relevant Annexes to the products being manufactured at your workplace.