|Program/Course ID: CGMP05|
Enrollment Period: 3 months.
Allocated Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Good Manufacturing Practice (cGMP).
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
PRICE: USD $195.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: GMP: Good Manufacturing Practice in Processing Medicinal Products
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment.
Operations in the dispensary and on processing lines are at the heart of medicinal product manufacturing. This module describes how to carry out such operations in compliance with the requirements of Good Manufacturing Practice.
We discuss how to: dispense starting materials; set up, control, and record formulation processes; evaluate product yield and calculate materials reconciliation. We set out the Good Manufacturing Practice (GMP) requirements that must be met in carrying out these tasks.
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.
An outline of the module's scope and objectives, and notes on terminology.
The dispensary is the place where raw materials entering the processing area are controlled. It is where starting materials coming from the warehouse are weighed and transferred into containers ready to be taken for formulation operations. Dispensing is a critical step in production and must be done with great care. Any error can have a substantial impact on product quality. In this session we discuss good practice in dispensing starting materials.
Formulation processes are the prime engines of pharmaceutical manufacturing. Control of these processes is central to the assurance of product quality. In this session we set out the main tasks involved in processing a batch after starting materials or intermediate product have been dispensed, and we describe relevant GMP requirements.
Yield and reconciliation
Product yield evaluation and material reconciliation are two ways of checking the balance between the amount of material input to a process and the amount output from it. If the balance does not lie within acceptable limits, this may indicate a problem with the process. In this short session we discuss the importance of yield and reconciliation, how to check them, and what must be done to comply with GMP requirements with regard to them.
Multiple-choice mastery assessment.
Who will benefit from this module?
This module provides essential training for all personnel who work on the processing of medicinal products. Other staff working in a manufacturing environment in the pharma/biotech industry will also benefit from this module.
- Dispense starting materials in compliance with GMP requirements
- Set up, control, and record formulation processes in compliance with GMP requirements
- Evaluate product yield and check materials reconciliation in compliance with GMP requirements
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.