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Home » Process Val: Introduction to Process Validation - Part 1

Process Val: Introduction to Process Validation - Part 1 (ELM-401)

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: Introduction to Process Validation - Part 1
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 this course you will learn about general terms used in process validation. We will explain why processes are validated, and will review regulations associated with process validation. It will also give you an insight on safety, business and regulatory benefits of performing process validation. This will be followed by a look at current validation and qualification practices and expectations and how these are now being globally harmonized.
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: Introduction to Process Validation - Part 1 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

Introduction
Overview
Fundamental terms
General sayings

Why Validate Processes
Overview
Why validate processes
Regulations
Regulations (Continued)
Benefits
Safety
Business
Regulatory
Validation and qualification
Harmonization

Initiation of Validation
Overview
Validation
Validation versus verification
What is process validation
What is validated
What processes to validate?
Determining whether to validate or if verification is sufficient
Who validates
What does the team do?
When to validate?
Prospective validation
Concurrent validation
Retrospective validation
Types of process validation in Europe
When to validate/revalidate
Design review
Process validation study

Validation Master Plan
Overview
Validation master plan
Whom does the VMP help
VMP planning
Contents of a master validation plan
Contents of the validation master plan
Approaches to the qualification of equipment
Approaches to the qualification of legacy equipment
The validation plan (qualifications)

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.

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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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