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Thursday, November 26, 2020
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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 Practices (GMP).
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 you will immediately receive a certificate of completion via PDF.

Benefits of Getting Certified at BioPharma Institute

Throughout many of our courses, students engage in active learning with the assistance of tools like videos, seminars (both recorded and live), online books, and more. At BioPharma Institute, we have the ability to cater to not only small-scale training, but large-scale training requests. Our capabilities include customizing training in a manner that meets with corporate or individual requirements. We offer programs that will train teams economically, and without the need for missing a full day of work in order to attend a day-long class.

For more than two decades we have provided solutions in online training for thousands of organizations in industries such as biotechnology, clinical research, pharmaceutical, and healthcare. Businesses can now train their employees without having to allocate time during which to conduct live classes, thanks to the more flexible scheduling offered by convenient e-learning courses.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information.


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

Full List of Programs in the Good Manufacturing Practices Catalog:



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

cGMP for Microbiology and Contamination Control Professional Certification Program: The GMP for Microbiology and Contamination Control Professional Certification Program offers a comprehensive overview of good manufacturing practice as it applies to contamination control and microbiology. It p ... Learn more

cGMP: An Introduction to Good Manufacturing Practice: This GMP course includes an introduction to current good manufacturing practices (cGMPs), information on maintaining product quality, the scope of GMP rules, a section on cleaning and sanitation, a look into pr ... Learn more

cGMP: Warehouse (Pharmaceuticals): The GMP for the Warehouse training program provides an overview and discussion of the role current good manufacturing practices has in the warehouse; and offers an emphasis in receipts, issues, storage, and dis ... Learn more

cGMP: Microbiology in the Workplace: The GMP: Microbiology In the Workplace training program offers a comprehensive overview of microbiology in the workplace, as it relates to current good manufacturing practices. The syllabus of this course inclu ... Learn more

cGMP: Cleaning and Sanitation: This Good Manufacturing Practice (GMP) in Cleaning and Sanitation training program offers a comprehensive overview and a solid introduction to cleaning and sanitation, as it relates to the regulator of quality ... Learn more

cGMP: Documentation and Record Keeping: This training program provides a comprehensive overview of current good manufacturing practices, with an emphasis on the role of proper documentation, and how it is used to provide a history of the manufacturin ... Learn more

cGMP: Contamination Control: This online training course offers a overview of good manufacturing practice with a comprehensive emphasis on contamination control. The program builds on microbiology in the workplace course, GMP03, and addres ... Learn more

cGMP: Production Controls: 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 ... Learn more

cGMP: Packaging Controls: 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 co ... Learn more

cGMP: Quality Assurance and Quality Control: This course emphasizes quality assurance and quality control, with respect to good manufacturing practices. Participants explore GMPs as they apply to quality testing, management, manufacturing, and the control ... Learn more

cGMP: Pharmaceutical CAPAs: This online training program describes corrective and preventive actions (CAPAs), and how good manufacturing practices can be applied to eliminate causes of non-conformities or other undesirable situations. The ... Learn more

cGMP: Introduction to Good Manufacturing Practice, An Abridged Course: The cGMP: Introduction to Good Manufacturing Practice, An Abridged Course is a shortened training program used primarily for demonstration purposes only. The full length course includes an introduction to curre ... 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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