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Home » Process Val: An Introduction to Process Validation - Part 2

Process Val: An Introduction to Process Validation - Part 2 (ELM-402)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Validation for BioPharma Companies.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: Process Val: An Introduction to Process Validation - Part 2
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 ReviewsIn the second part of our program on process validation, you will learn in more detail, the different steps that constitute process validation. We will look at the qualification of equipment and the steps that need to be performed during a validation study. This will also include a discussion of the validation protocol, how it should be written and approved. Finally, we discuss the differences between the traditional and the new life cycle approach.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


Process Val: An Introduction to Process Validation - Part 2 course is included in the following Professional Certification Programs:



Process Validation for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

COURSE OUTLINE:


Introduction
Overview
Course structure
Learning objectives
Who should take this course?
Course modules

Equipment Qualification Stages of Process Validation
Overview
Qualification of equipment
Design qualification
User requirement specification
Functional requirement specification
Operational requirements
Vendor qualification
Installation qualification
Installation qualification protocol
Operational qualification
Operational qualification protocol
Performance qualification
Review activity

Process Validation
Overview
What is process validation?
The stages of process validation
Stage 1: Process design
Stage 2: Process validation
Stage 3: Continuous process validation
Review activity

Traditional Approach to Process Validation
Overview
Traditional Approach
Modern Approach to Process Validation
Traditional vs New Life Cycle Approach to Validation
Quality Risk Management
Quality by Design
Quality by Design (Continued)

Conclusion


Final Exam


Certification


COURSE OBJECTIVES:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of Process Validation.

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.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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