Enrollment Period: 12 months (1 year).
Average Learning Time: ~12 - 18 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Courses: Program includes 8 individual courses (see below).
Digital Badge: Issued upon completion.
Post-nominal Letters: GLPro™.
Catalog: Good Laboratory Practices.
Demonstration: Five (5) free trial courses are available.
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 from Biopharma InstituteTraining Provided By: Biopharma Institute
By taking this 8-course professional certification program, students will be able to explain the principles of current good laboratory practices (cGLP) and 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. 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.
On completion of this program students will 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 discusses 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 your work, it is important to remember that the laboratory records you create are the original and legal record of your work. This program is intended for professionals and others who are employed in regulated (cGLP and current Good Manufacturing Practice) or accredited (ISO 17025) laboratories and 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.
In this program a detailed explanation of what events and circumstances should trigger a laboratory investigation, followed by an overview of the laboratory investigation. Next, we will turn the discussion to the details of conducting a laboratory investigation within a cGLP/cGMP environment. It will cover all three phases of the laboratory investigation, along with the details of the laboratory investigation report and laboratory investigation tracking.
Review the individual courses included in this program (see below) for program descriptions and outlines.
Good Laboratory Practice (GLP) Professional Certification Program includes these courses:
Certification Requirements: Students must view the entire program and successfully pass online, multiple-choice final assessments for each course within a 180 day/6-month period. Certificate of completion is accessible in PDF format immediately after satisfying the 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. Program enrollees can 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 certification ID code. The professional 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 validate the training achieved. Digital badges can be displayed on social networking sites, such as LinkedIn.
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.
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-scale (1-100 students) and large-scale (100+ students) training requests.
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.