Student Login |

Friday, June 18, 2021
Home » GLP: How to Prepare for Internal & External Laboratory Audits

GLP: How to Prepare for Internal & External Laboratory Audits (ELM-106)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Good Laboratory Practices.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

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

Biopharma Institute LogoTraining Program: GLP: How to Prepare for Internal & External Laboratory Audits
Training Provided By: Biopharma Institute

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

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsThis course will examine the formal laboratory audit from the perspective of the laboratory being audited. By the end of this course you 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
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

GLP: How to Prepare for Internal & External Laboratory Audits course is included in the following Professional Certification Programs:

Good Laboratory Practice (GLP) Professional Certification Program: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more


Learning objectives
Who should take this course
Module overview

Introduction to Audits
Approaches to audits
How audits are usually performed
Strategy for handling formal audits

Permitting Photography, Video, Sound Recordings and Providing Documents
The question on permitting photography, video and sound recordings
Policy of the use of photography, video and sound recording during audits
What documents should be shown to the inspectors
Documents that should not be reviewed
Review activity

What will the Auditor Inspect?
Roles of staff directly involved in the audit
What will the inspectors audit
Review of laboratory investigations and deviations
Study and testing plans
Sample management
Reference standards
Laboratory instrumentation
Laboratory operations

Audit Preparation and Participation
Maintaining audit readiness
Commonly requested items
Role of the audit coordinator
The operations center
During the audit - opening meeting
Answering auditors questions
Tour of the laboratory and facility
Exit meeting
Review activity

Audit Follow Up and Obstructing Regulatory Audits
Audit follow-up
Obstructing regulatory audits
Acceptable explanations
Key points moving forward


Final Assessment



Skill Level:

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

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.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

Information Request / Suggest a Course Form:

Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us with as much detail as possible about your training project):