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Wednesday, December 01, 2021
Home » Validation: Equipment Cleaning Validation

Validation: Equipment Cleaning Validation

Certification Training
 
Rated 4.07/5
15 reviews
Program/Course ID: VAL08
Enrollment Period: 6 months.
Average Learning Time: ~90 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1.5 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Validation for BioPharma Companies.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $195.00 USD  

Document your dedication to compliance, safety, and job performance by earning a training certification from Biopharma Institute

Training Program: Validation: Equipment Cleaning Validation
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

This online program offers an introduction to the international principles and regulations behind equipment cleaning validation. Manufacturers of medicines and healthcare products must establish, validate and maintain an equipment cleaning program. This is a regulatory requirement because validated cleaning procedures contribute to the assurance of product purity and safety. This module provides a comprehensive account of equipment cleaning validation requirements and procedures. It follows the work of a pharmaceutical company's validation team as they establish and validate the cleaning program for a new production line.

Course training objectives include: To analyze cleaning validation results and the preparation of reports, to develop and execute cleaning validation protocol, to determine your criteria on cleanliness, to offer a definition of cleaning validation prerequisites, to explain the factors that determine your cleaning validation scope, and to explain regulatory requirements and a definition of cleaning validation terminology.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


Outline:


Introduction
An introduction to the validation project that provides a case study on validation, plus definitions and a glossary.

Scope of cleaning validation
This session compares and contrasts different approaches to equipment cleaning validation: equipment-train vs individual item; common vs dedicated equipment; batch-to-batch vs product-to-product cleaning; automated vs manual. It identifies requirements that cleaning SOPs need to meet. It explains the bracketing of products for cleaning validation. It outlines the qualification of clean-in-place systems, and the use of previous cleaning validation data. Finally, it describes techniques for testing surface residues.

Validation of test methods
This session identifies analytical techniques that are appropriate for cleaning validation studies. It defines limit of detection (LOD) and limit of quantitation (LOQ). Finally, it explains how to carry out swab recovery studies.

Acceptance criteria
This session identifies factors to be considered when determining acceptance limits for product carryover. It explains how to use toxicity and solubility data in determining acceptance criteria. It describes the selection of worst-case, follow-on, and representative products for cleaning validation studies. It explains how to calculate Maximum Allowable Carryover (MAC), and Surface Area Limit (SAL) for swab testing.

Writing and executing protocols and writing reports
This session identifies essential elements of a cleaning validation protocol. It describes how to specify worst-case conditions for cleaning validation, and sampling at the most difficult-to-clean locations. It explains why a cleaning validation protocol is usually applied to actual batch manufacture. It provides checklists for preparedness to execute a cleaning validation protocol, and for the documentation of results. It summarizes the content of a cleaning validation report. Finally, it outlines ongoing cleaning requirements after validation.

Assessment
The assessment tests the learner's assimilation of the module's content.

Objectives:


Who will benefit from this module?
Manufacturing personnel in the pharma/biotech, dietary supplement, and medical devices industries need to understand the principles and practice of cleaning validation, as set out in this module. In particular, the module provides essential learning for engineering, production, and quality management personnel in the pharmaceutical industry.

Learning objectives
  • Define cleaning validation terminology, and explain regulatory requirements
  • Determine the scope of cleaning validation
  • Carry out and validate tests of cleanliness
  • Determine acceptance criteria
  • Develop and execute a cleaning validation protocol
  • Analyze and report cleaning validation results, and outline an ongoing cleaning and monitoring program

Validation: Equipment Cleaning Validation is included in the following professional certification programs:



Professional Certification Program:

Pharmaceutical Validation Management Professional Certification Program

Course ID: VAL00S1
Price: $1299.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale (1-100 students) and large-scale (100+ students) training requests.


Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.


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