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cGMP: Packaging Controls (GMP08)

Certification Training
 
Rated 4.06/5
16 reviews
Method of Training: Online / Self-paced eLearning.
Credit Hours: 2 credits.
Duration: ~2 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Good Manufacturing Practice (cGMP).
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: cGMP: Packaging Controls
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 Reviews

The good manufacturing practice in packaging controls program describes cGMP requirements for the control of packaging materials and operations. Students will explore the reasons that labeling problems still constitute one of the most common reasons contributing to product recalls. The objectives of this course are to teach procedures for label control, line clearance, verification procedures, and procedures for reconciliation. The curriculum covers an introduction, printed material control, line clearance and set up, on-line controls, reconciliation, and a summary of all the above stated material.

Once all course requirements have been satisfied, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate cGMPs and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


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.


COURSE OUTLINE:


Introduction
- Objectives
- Reviews and assessment
- Overview

Mislabelling
- What do you think?
- What do the GMP rules state?
- Overview
- Packaging controls
- Labelling recalls

Printed material control
- What do you think?
- What do the GMP rules state?
- Overview
- Printing
- Receiving printed material
- Issue, coding and returns
- Match the controls to the process stages
- Select true or false for each statement

Line clearance and setup
- What do you think?
- What do the GMP rules state?
- Overview
- Line clearance
- Line setup
- Clean-up

Line clearance and setup (continued)
- Order these steps for a given batch
- True or false?
- What is the difference between line clearance and line clean-up?

Online controls
- What do you think?
- What do the GMP rules state?
- Overview
- Checking fill volume and seal integrity
- Run charts
- Control charts
- For the 5 bottles examined, which is the best deviation description?
- Which checks are required during packaging operations? Select all that apply.

Reconciliation
- What do you think?
- What do the GMP rules state?
- Overview
- Calculating reconciliations
- Reconciliation walk-through
- Unsatisfactory reconciliation may indicate what? Select all that apply.
- Select true or false for each statement.

Conclusion
- Summary

COURSE OBJECTIVES:


This module describes the GMP requirements for the control of packaging materials and packaging operations.


- Define mislabelling
- State requirements for packaging controls
- Describe GMP controls for pre-printed matter
- Identify GMP requirements of setting up a packaging line
- State the importance of on-line controls
- Perform basic reconciliation calculations

The cGMP: Packaging Controls Course is Included in the Following Professional Certification Programs:


Current Good Manufacturing Practice (cGMP) Professional Certification Program: The Current Good Manufacturing Practice (cGMP) Professional Certification Program provides a comprehensive overview on the best practices regarding management of manufacturing and quality control testing for ph ... Learn more

Online Training: The Benefits of 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 requirements.
  • 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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