Enrollment Period: 12 months (1 year).
Average Learning Time: ~12 - 18 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 8 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 8 individual courses:
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessments 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 the accomplishment.
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 catering to both small and large-scale training requests.
Benefits of Training with Biopharma Institute
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
- Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
- Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
- Purchase orders (POs): If issuing 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.
- Reimbursement: Some employers may reimburse for training expenses. Check 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.
- Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
- Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.