Method of Training: Online / Self-paced eLearning.Credits: 1.5 CPD Credits.
Duration: ~90 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $195.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: GMP: An Introduction to Good Manufacturing Practice for 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.
Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. The rules may be written into law or set out in guidance documents from regulatory authorities. Regulators will not allow medicinal products to be placed, or to remain, on the market in their country unless the products can be shown to be manufactured in compliance with GMP. To this end, they carry out inspections of manufacturing plants. Companies that persistently commit serious breaches of GMP requirements have suffered huge fines.
All manufacturing personnel must receive initial and ongoing training in the theory and practice of GMP. Everyone who works in a processing, quality control, packaging, or warehouse environment for a pharmaceutical or biotechnology company, or one of their contractors, must understand why GMP is important, how it applies to them, and how to comply with it. This module provides an ideal induction and refresher course in the basics of GMP. We begin by explaining what GMP is and why it is necessary. We then set out its main principles. Finally, we focus on two aspects of GMP that apply to everyone in the manufacturing environment: hygiene, cleaning, and sanitation; and documentation.
Once all course requirements have been satisfied, a Certificate of Completion is immediately available. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade.
Benefits of Getting Certified at Biopharma Institute
By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the Biopharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The Biopharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. By coupling new automated tracking systems with proven and advanced e-learning training techniques, the Biopharma Institute can do for you and your company what we have done for numerous companies - both abroad and within the USA. We can assist in the maintaining of training records, the education of your employees, and with an overall improvement in the quality of service you offer.
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.
An outline of the module's scope and objectives, and notes on terminology.
GMP... what and why:
This session explains what GMP is and why it is important, and it gives some lessons from history. It introduces the regulations and guidance documents which are the source of GMP rules. Finally it touches on regulatory inspections and the consequences that can arise from failure to comply with GMP requirements.
Principles of GMP:
In this session we present an overview of the main principles of GMP, and we outline some things that manufacturing personnel need to do to comply with requirements. We identify the principal goals of GMP as: prevention of contamination; prevention of mix-ups; scrupulous documentation; validation and maintenance of processes and equipment; quality assurance by an independent unit; and training. We place GMP in the context of a company's quality management system.
Hygiene, cleaning, and sanitation:
Prevention of contamination is one of the most important goals of GMP. Contamination of product is often difficult to detect, so GMP rules emphasize preventive measures, including: attention to personal health and hygiene, and the wearing of special clothing, by staff; and cleaning and sanitation of premises and equipment. In this session we set out the basics of GMP requirements in these vital areas.
Documentation and records:
Comprehensive documentation of procedures, formulas, work instructions, and specifications, and thorough recording of batch data, are fundamental requirements of GMP. In this session, we explain why documentation is so important, identify different types of document required, and set out some simple rules for recording and correcting data.
Multiple-choice mastery assessment.
Who will benefit from this module?
Everyone who works in, or has occasion to enter into, a manufacturing environment in the pharma/biotech industry should have access to this module.
- State what GMP is and describe why it is important
- Identify sources of GMP rules in regulations and internationally standardized guidance
- Identify major goals of GMP, outline what manufacturers must do to achieve them, and list some of the things that you need to do in order to contribute
- Comply with basic requirements regarding hygiene, cleaning, and sanitation
- Comply with basic requirements regarding documentation
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.