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GLP: Laboratory Investigations & Deviations

Certification TrainingProgram/Course ID: ELM-108
Enrollment Period: 3 months.
Allocated Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Good Laboratory Practices.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Training Program: GLP: Laboratory Investigations & Deviations
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsOn completion of this course you 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 acGMP/cGLP environment and explain the detailed procedure for all phases of conducting and documenting a laboratory investigation.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying 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. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The 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 verify training, and can be displayed on social networking sites, such as LinkedIn.


Outline:


Introduction
Overview
Learning objectives
Who should take this course
Course modules

Meaningful Investigations
Overview
Meaningful investigations
Definitions

Regulatory Requirements
Overview
Regulatory requirements
EU cGMP
US GMP
ISO
cGLP
Guidance

The Barr Decision
Overview
Barr decision
Barr decision - Barr's testing procedures
Findings of the court
Conclusions

Conducting a Laboratory Investigation
Overview
What should be investigated?
Conducting a laboratory investigation
Phase 1(a) of the investigation - Identification of obvious errors
Phase 1(b) Investigation
Phase 1(b) Investigation Part 2
Phase 2 investigation
Retesting
Assessing the results from retesting
Investigation of stability out of specification and suspect results
Handling laboratory investigations
Phase 3 investigation
Review activity

Documenting a Laboratory Investigation
Overview
Documenting laboratory investigations
Tracking laboratory investigations
Laboratory investigation case study
Laboratory investigation report
Information about the investigation
Description of event results in the investigation
Phase 1(a) investigation
Phase 1(b) of the investigation
Phase 2 investigation - Testing protocol
Phase 2 investigation findings
Phase 2 investigation - conclusion
Phase 3 of the investigation
Section 3 impact and disposition
Corrective and preventative action plan
Classification

Conclusion


Final Assessment


Certification

Objectives:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of Good Laboratory Practices (cGLP).

GLP: Laboratory Investigations & Deviations is Included in the Following Professional Certification Program(s):



 Professional Certification Program: 
Good Laboratory Practice (GLP) Professional Certification Program
Course ID: GLPPRO
Price: $1295.00 (USD) | Learn more

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.


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