cGMP: What is GMP and Why is it Important (Fundamentals: 1 of 4)
 | Enrollment Period: 12 months. Average Learning Time: ~15 minutes. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials.Credit Hours: 0.5 credits. Digital Badge: Issued upon completion. Catalog: Good Manufacturing Practice (cGMP). Demonstration: Three (3) free trial courses are available. Group/Employee Training: Click here to request a quote. Final Assessment: Multiple choice; unlimited attempts. Certificate: PDF with validation code (See sample). Price: $99.00 USD |
Download Program DetailsDocument your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: cGMP: What is GMP and Why is it Important (Fundamentals: 1 of 4)Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  This is a micro learning course: A 30-minute course designed to introduce new employees or reinforce seasoned employees on GMP guidelines. It is used to encourage awareness of the importance of following GMP guidelines. 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 by explaining what GMP is and why it is necessary. Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements. Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance. Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion. Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr. |
Outline:Module overview: 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. Assessment: Multiple-choice mastery assessment. | Objectives: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. This is a great GMP refresher training program for those working in a GMP environment. Learning objectives - State what GMP is and describe why it is important | |
Benefits of Training with Biopharma Institute
| Immediate access to courses: | Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment. |
| Self-paced, asynchronous eLearning: | 24/7 access to all course materials and assessments for 12 months. |
| Open enrollment: | No prior course prerequisites or work experience required. |
| Expertise: | Courses developed by subject matter experts (SMEs) in the area being taught. |
| Current and validated: | Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited. |
| Optimized for learning: | Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter. |
| Secure and safe access: | Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance. |
| Flexible final assessments: | Multiple-choice questions can be taken repeatedly until a passing score is achieved. |
| Direct access to certificates: | Certificate of completion is instantly available once requirements have been fulfilled. |
| Verification of training: | Certificates verifiable online with digital badges issued for all professional certification programs. |
| Training manager access: | A proprietary portal offers access to download enrollment reports, training records, account balance, and more. |
| SCORM-compliant courses: | Courses can be delivered directly to most corporate Learning Management Systems (LMS). |
| Purchase orders (POs): | POs are accepted from all companies. Request an invoice when starting the procurement process. |
| Reimbursement: | Some employers may reimburse their employees for training expenses. Check your company's policy. |
| Financial assistance: | Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option. |
| Career advancement: | Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties. |
