Good Laboratory Practice (GLP) Professional Certification Program
Enrollment Period: 12 months.
Average Learning Time: ~14 - 20 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online, asynchronous, self-paced eLearning.Accessibility: 24/7 access to all program materials.
Courses: Program includes 9 individual courses (see courses).
Outline/Syllabus: See individual course pages for outlines.
Digital Badge: Issued upon completion.
Post-nominal Letters: GLPro™.
Catalog: Good Laboratory Practices.
Demonstration: Five (5) 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: $1295.00 USD
Document your dedication to compliance, safety, and job performance by earning a professional certification.Training Provided By: Biopharma Institute
Outline/Syllabus: See individual course pages for outline.
Students completing this professional certification will be able to explain the principles of current good laboratory practices (cGLP), its importance within a regulated laboratory environment, the benefits of cGLP, and how it leads to the creation of technically defendable scientific data, by which its quality, reliability, and trustworthiness can be assured. This program teaches the regulations and standards associated with cGLP, the fundamental requirements of cGLP, and the consequences of non-compliance for regulated laboratories.
It is critical that the data generated in a regulated laboratory is accurate and trustworthy. This program provides the necessary knowledge and skills to ensure that attendees can fully integrate data integrity into laboratory quality management systems, thus ensuring that all scientific data delivered by analytical testing laboratories is both reliable and trustworthy. This program will examine the formal laboratory audit from the perspective of the laboratory being audited. By the end of this program students will be able to explain the different approaches the auditor can follow during an audit, the things the auditor will be looking for during a typical laboratory audit, an overview of a strategy the laboratory can use to handle audits, what the laboratory can do to prepare for the audit, how to handle the progress of an audit, how to follow up after completion of an audit, and what constitutes obstructing regulatory audits.
Students will further be able to, explain the elements of a meaningful laboratory investigation, define commonly used terms related to laboratory investigations, discuss the applicable cGMP/cGLP regulations and guidance related to laboratory investigations, explain the details and significance of the Barr Decision as it relates to laboratory investigations in a cGMP/cGLP environment, and explain the detailed procedure for all phases of conducting and documenting a laboratory investigation.
This program goes further to discuss one of the most important topics in current Good Laboratory Practice for laboratory staff. That is, how to carry out and document your laboratory work in a compliant manner. When performing and documenting work, it is important to remember that the laboratory records created are the original and legal record of work. This program is intended for professionals who are employed in a regulated (cGLP and current Good Manufacturing Practice) and/or accredited (ISO 17025) laboratory. It is intended to form a core training syllabus for laboratory management and scientific personnel.
The objective of Current Good Manufacturing Practices (cGMP) is to control the quality of pharmaceutical products, and therefore the purpose of laboratory investigations in a cGMP environment is to identify how adverse events that occur during the manufacture of products can impact on the safety, quality, and efficacy of those products. During laboratory testing, sometimes out of specification (OOS), unexpected and suspect, results are obtained. Events which cause a deviation from established laboratory procedures can also happen. This program will teach how to manage through these events. In this program, a detailed explanation of what events and circumstances should trigger a laboratory investigation is followed by an overview of the laboratory investigation. Then, we will turn the presentation to the details of conducting a laboratory investigation within a cGLP/cGMP environment.
This program will cover all three (3) phases of the laboratory investigation, along with the details of the laboratory investigation report, and laboratory investigation tracking.
Courses included in this program: GLP: An Introduction to Good Laboratory Practices (GLP); GLP: Laboratory Data Integrity and the Principles of ALCOA (GDocP); GLP: How to Prepare for Internal & External Laboratory Audits; GLP: Laboratory Investigations & Deviations; GLP: Performing Analytical Analysis in a Regulated Laboratory; GLP: Organization, Roles and Infrastructure for Regulated or Accredited Laboratories; GLP: The Basics of Laboratory Investigations; and GLP: How to Conduct a Laboratory Investigation.
Good Laboratory Practice (GLP) Professional Certification Program includes these 9 individual courses:
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment for each course within a 12-month period. Certificate of completion is accessible in PDF format immediately 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 or recertification period for employee compliance training would be determined by those responsible for managing quality within the company.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into any program or course. Students may attempt the final assessments any number of times, as needed, to achieve a passing score.
Once all training requirements have been satisfied a professional certification has been achieved and can be verified immediately from our website using a unique ID code located on the certificate. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format.
Additionally, once the student has completed the professional certification program, a digital badge is issued. The digital badge documents all the courses taken and completed within the program, to further validate the student's achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Badgr, and others, to display accomplishments.
Benefits of Being Certified from Biopharma Institute: Throughout the online training courses students will be engaging in active learning using interactive eLearning modules developed to promote the retaining of key knowledge. Furthermore, students will be provided with access to references, the regulatory guidelines, case studies, and other important information necessary to gain a professional understanding for the discipline.
Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with attaining their training requirements. Our courses are developed by subject matter experts (SMEs) in the topic of study and have all been validated and/or accredited by a neutral 3rd party. Biopharma Institute certifications are recognized by regulators and companies in a wide range of industries around the world.
Biopharma Institute has training solutions which are customizable to any organization's training needs. We aim to provide only the highest quality of training, which is current, engaging, effective, and easy to navigate.
Today, Biopharma Institute has over 200+ courses in its catalog. These courses train on clinical trials, drug manufacturing, regulatory affairs, validation systems, drug safety, pharmacovigilance, good laboratory practice, and data integrity; all within the medical device, clinical research, and pharmaceutical industries.
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 cater to both small and large-scale training requests.
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.|