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Validation: Equipment Cleaning Validation

Validation: Equipment Cleaning Validation Certification Training

 
Rated 4.1 / 5
(15 reviews)

Program/Course ID:VAL08
Enrollment Period:12 months.
Average Learning Time:~90 minutes.
Additional Resources:Supplemental materials/activities.
Accredited Program:1.5 CPD Credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Catalog:Validation for BioPharma Companies.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
Special New Year 25% Discount:Use this discount code: 2024NEWYEAR.
Discounted Price:
   $146.25 USD  
  Price: $195.00 USD  
CPD Accredited Training

Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.

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 12-month period. 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 promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.


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

This Course is Included in the Following Professional Certification Program(s):



Professional Certification Program:

Pharmaceutical Validation Management Professional Certification Program

Program ID: VAL00S1
Price: $1299.00 (USD)

Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further 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 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries.

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 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.


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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.


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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For quotes or invoices please provide the course(s) and number of students.