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Clinical Trials: Preparing for an Audit or Inspection

Clinical Trials:  Preparing for an Audit or Inspection Certification Training
 
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Program/Course ID: GCP006
Enrollment Period: 12 months.
Average Learning Time: ~150 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 2.5 CPD Credits.
Method of Training: Online, asynchronous, self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
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: $225.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a training certification.

Training Program: Clinical Trials: Preparing for an Audit or Inspection
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

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

Description:
Biopharma Institute Reviews

Good Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the results of the trials are accurate and reliable; and the trials are carried out in compliance with relevant legal requirements.

This module describes what investigational medicinal product sponsors, contract research organizations and clinical investigators can expect when they undergo inspection or audit. It focuses in particular on inspection by European and US regulators.

The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format 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 period for employee compliance training would be determined by those responsible for managing quality assurance.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


Outline:


Module overview
An outline of the module's scope and objectives, and notes on terminology.

Principles of GCP inspections and audits
Principles, applicable in any regulatory jurisdiction, of inspections and audits: their purpose, who carries them out, in what circumstances, and their possible consequences; routine versus targeted inspections; system versus study-specific inspections.

Preparing for an inspection
Actions you can take to prepare your site for a GCP inspection, whether you work for a sponsor or CRO or as a clinical investigator.

European regulators' inspection of sponsor and CRO sites
Procedure for inspection of the site of a sponsor or CRO by the regulatory authority of a member state of the European Economic Area: pre-inspection provision of an inspection request and plan to the inspectee; quality system inspection; study-specific inspection.

European regulators' inspection of investigator sites
Inspection of legal and administrative aspects, organizational aspects, informed consent provisions, subject data, and management of investigational medicinal products.

FDA inspection of sponsor and CRO sites
An outline of pre-inspection activity among the relevant FDA offices is followed by detailed description of what the inspectors examine as regards organization and personnel, study registration, selection and monitoring of investigators, study monitoring, quality assurance, safety and adverse event reporting, data collection and handling, record retention, financial disclosure, computer systems, electronic records and signatures, and investigational product.

FDA inspection of investigator sites
An outline of investigators' legal obligations and the possible scope of an inspection is followed by detailed description of what the inspectors examine as regards authority and administration, clinical protocol, institutional review board, informed consent, source documents, CRFs, financial disclosure, investigational product control, records retention, reports to sponsor, and monitoring.

Action after an inspection or audit
This session describes post-inspection actions by regulators, and responses by inspected parties, with particular reference to European and US regulators: meetings at the close of inspections, inspection reports, classification of findings, responses and action plans, post-inspectional correspondence, and possible consequences of serious deficiencies.

Assessment
Multiple-choice mastery assessment.

Objectives:


Who will benefit from this module?
This module will benefit all those involved in clinical research who already understand the basics of GCP. It will be of value to staff working in clinical, medical and QA departments of pharmaceutical companies and CROs, to independent clinical research associates, and to healthcare professionals conducting clinical studies.

Learning objectives
  • Discuss principles of GCP inspections and audits
  • Specify activities to be carried out in preparation for an inspection
  • Describe what happens when a European regulator inspects the site of a sponsor or contract research organization
  • Describe what happens when a European regulator inspects the site of a clinical investigator
  • Describe what happens when the US Food and Drug Administration inspects the site of a sponsor or contract research organization
  • Describe what happens when the US Food and Drug Administration inspects the site of a clinical investigator
  • Specify post-inspection actions by the regulator and the inspected party

Clinical Trials: Preparing for an Audit or Inspection is included in the following professional certification programs:



Professional Certification Program:

Clinical Research Associate (CRA) Professional Certification Program

Course ID: GCP00A
Price: $845.00.00 (USD) | Learn more

Professional Certification Program:

Clinical Trials Management (US & EU) Professional Certification Program

Course ID: GCP00A1
Price: $1295.00.00 (USD) | Learn more

Professional Certification Program:

Clinical Research Coordinator (CRC) Professional Certification Program

Course ID: CRCPRO
Price: $995.00.00 (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 validated by 3rd party organizations for relevancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

Group Training for Employees: 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 and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.


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.



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