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Friday, June 18, 2021
Home » CC: An Introduction to Cleaning Validation

CC: An Introduction to Cleaning Validation (ELM-601)

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: Contamination Control.
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: CC: An Introduction to Cleaning Validation
Training Provided By: Biopharma Institute

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

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsThis course has been created for anyone who is interested in learning more about cleaning validation within a regulated environment. If you would like to expand your knowledge of cleaning validation, but find it difficult to get involved on cleaning validation projects, this course is the perfect starting point.
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.

CC: An Introduction to Cleaning Validation course is included in the following Professional Certification Programs:

Pharmaceutical Contamination Control Professional Certification Program: The cGMP for Microbiology, Quality Control and Contamination Control Professional Certification Program offers a comprehensive overview of current good manufacturing practice (GMP) and Good (Quality Control) La ... Learn more


Learning objectives
Who should take this course?
Course modules

The Starting Line
The predicate rules and best practices
Why clean?
Potential contaminants
What is cleaning validation?
Why perform cleaning validation?

Rules and Guidelines
Regulatory requirements
Cleaning validation regulatory requirements
Cleaning validation guidelines

The Cleaning Validation Process
The scope of cleaning validation
The cleaning validation sequence
Cleaning validation strategy, plan and policy
Campaign production and batch production
Minor and major equipment
Dedicated equipment
Grouped products
Grouped equipment
Worst case
Analytical methods
Swab sampling
Rinse sampling
Visual examination
Placebo testing
Direct surface monitoring
Recovery studies
Recovery factor
Analytical method selection and development
Analytical method validation
Acceptance criteria
Acceptance limits
Not set by regulatory agencies
Industry limits
Based on therapeutic dose
Based on toxicity
Based on analytical detectability
Based on process capability
Microbial acceptance limits
Cleaning method development
Critical sites
Master validation plan
Cleaning validation plan
Cleaning process SOP
Cleaning validation protocols
Term sheets
Protocol execution
Clean and dirty hold times
Dirty hold times
Clean hold times
Validation report
Post validation monitoring
Maintaining the validated state
Retrospective cleaning validation
When is retrospective validation permitted?
Retrospective cleaning validation flow diagram


Final Exam



Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of Contamination Control and Aseptic Techniques.

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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