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cGMP: Production Controls

Certification Training
 
Rated 4.06/5
18 reviews
Program/Course ID: GMP07
Enrollment Period: 6 months.
Average Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Credit Hours: 2 credits.
Catalog: Good Manufacturing Practice (cGMP).
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $199.00 USD  

Document your dedication to compliance, safety, and job performance by earning a training certification from Biopharma Institute

Training 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.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


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

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

cGMP: Production Controls is included in the following professional certification programs:



Professional Certification Program:

Current Good Manufacturing Practice (cGMP) Professional Certification Program

Course ID: GMP001S1
Price: $1795.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale (1-100 students) and large-scale (100+ students) training requests.


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:

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