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Tuesday, May 17, 2022
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 quality, compliance, safety, and job performance by earning a training certification.

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 enrollment.

Description:
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 course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


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 validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

Group Training for Employees: 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 and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.


Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Optimized for learning: Courses include voice-overs, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Purchase orders (POs): If a PO is required by your company, request an invoice to start the procurement process. we accept all purchase orders.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Tuition reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • 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.
  • 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 requirements have been fulfilled.


Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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