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cGMP: Production Controls (GMP07)

Certification Training
 
Rated 4.44/5
9 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: Production 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

This program offers an overview of good manufacturing practice, with a comprehensive emphasis on production controls. The program builds on GMP06, the contamination control course. The course will describe and define starting material controls, dispensing controls, processing controls, process monitoring, and handling deviations. Most importantly, the course will address the proper actions to be taken when confronted with materials that are nonconforming. The course objectives cover how to perform reconciliation and yield calculations, the purpose of clearance procedures, and why strict manufacturing controls are needed.

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

Starting material control
- What do you think?
- What do the GMP rules state?
- Overview
- Introducing starting materials to production
- 1. Receiving
- 2. Sampling and testing
- 3. Status labelling
- 4. Storing
- 5. Issuing
- Order these steps of starting material control
- When does direct control over product quality begin?
- Why are storage conditions critical to product quality?

Dispensing control
- What do you think?
- What do the GMP rules state?
- Overview
- Dispensing process
- 1. Room clearance
- 2. Setup
- 3. Weighing
- 4. Clean-up
- When does room clearance occur?
- Select true or false for each statement.

Processing control
- What do you think?
- What do the GMP rules state?
- Overview
- Room and line clearance
- Introducing materials
- Formulation controls
- In-processing checks
- Monitoring processes
- Testing line samples
- Batch records
- Cleaning-up
- Examples of GMP regulatory citations
- Match the terms and activities
- Select true or false for each statement

Deviations
- What do you think?
- What do the GMP rules state?
- Overview
- Handing deviations and CAPA
- Describe the deviation

Yield and reconciliation
- Overview
- Theoretical yield and expected yield
- Actual yield
- Reconciliation
- GMP for yield and reconciliation
- Match the terms
- True or false?

Conclusion
- Summary

COURSE OBJECTIVES:


This module looks at the controls for starting materials, dispensing and processing, then it addresses what actions to take when confronted with a deviation and how to calculate yield and reconciliation.


- Identify controls required for receiving, storing and dispensing starting materials
- Identify process controls in room and line clearance, formulation, in-process checks and batch records
- State GMP requirements for handling deviations
- Recognize how yield and reconciliation are calculated

The cGMP: Production 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.

Contact Us:

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