Student Login |


Friday, June 18, 2021
Home » CC: How Deviations (Non-Conformance's) Should be Handled from a Regulatory Perspective

CC: How Deviations (Non-Conformance's) Should be Handled from a Regulatory Perspective (ELM-712)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~30 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: How Deviations (Non-Conformance's) Should be Handled from a Regulatory Perspective
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 ReviewsThis course focuses on defining the term deviation (nonconformance) and further discusses the expectations of the regulatory bodies in the United States and Europe. The purpose of this course is to provide a general understanding of deviations and how they should be handled when they occur.
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: How Deviations (Non-Conformance's) Should be Handled from a Regulatory Perspective 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

COURSE OUTLINE:


Introduction
Overview
Learning Objectives
Who Should Take This Course?

Deviations (Nonconformances)
Deviation (Nonconformance) Definition
Examples of Deviations

European Union - EudraLex
Eudralex: Chapter 1.4, IX
Eudralex: Chapter 1.8, VII
Eudralex: Chapter 1.10, IV
Eudralex: Chapter 4, Quality Control, 4.29
Eudralex: Chapter 5, Production, 5.15
Eudralex: Chapter 5, Production, 5.44
Eudralex: Chapter 6, Quality Control, 6.33

United States Food and Drug Administration (FDA)
FDA: Section 211.100 Written Procedures; Deviations
FDA: Section 211.160 General Requirements
FDA: Section 211.111 Time Limitations on Production

Systematic Approach
Systematic Approach Overview

Conclusion


Final Exam


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

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.

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.

Information Request / Suggest a Course Form:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us with as much detail as possible about your training project):