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Home » GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 3 of 3)

GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 3 of 3)

GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 3 of 3) Certification Training

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Program/Course ID:ELM-124
Enrollment Period:12 months.
Average Learning Time:~45 minutes.
Additional Resources:Supplemental materials/activities.
Accredited Program:0.1 CPD Credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Catalog:Good Manufacturing Practice (cGMP).
Demonstration:Four (4) free trial courses are available.
Group/Employee Training:Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
  Price: $199.00 USD  
CPD Accredited Training

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

Training Program: GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 3 of 3)
Training Provided By: Biopharma Institute

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

Biopharma Institute ReviewsThe US Food and Drug Administration (FDA) is responsible for regulating the safety, efficacy, and quality of therapeutic products that save or improve human lives. Firms looking to approve pharmaceuticals, biopharmaceuticals, and medical devices must comply with these regulations or face sanctions and/or setbacks. FDA pre-approval inspections will focus on the past (corroboration of the data on which approval will be based), present (your organizational structure, delegation of responsibilities, written procedures, quality systems, culture of compliance) and future (your understanding and readiness for post-approval statutory obligations, including commercial vigilance plans).

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'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 promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.

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.


Learning objectives
Who should take this course?
Course modules

Introduction to GMP Auditing
What is an audit?
Why GMP audit?
Safety, business and compliance
Types of GMP audits
Internal audit (Self inspection)
Regulatory audits
Who conducts GMP audits?
Key principles of GMP audits - Auditors
Key Principles of GMP audits - Process
Benefits of GMP audits

The GMP Audit Process
The GMP audit process

Phase 1: Preparation and Planning of the GMP Audit
Determine the basis for the audit
What is the purpose of the audit?
What is your role?
What are the standards?
What is the scope?
Determine the feasibility of the audit
Review documents
Prepare the audit plan
Audit plan communication
Prepare work documents

Phase 2: Performing the Quality Audit
The audit process
The opening meeting
Avoid unproductive meetings
The site area tour
Collect information
Records review
Beginning the conference room pilot
Auditing techniques
Horizontal auditing
Vertical auditing
The ideal combination
Other auditing techniques
General audit findings
The daily wrap up
Classify audit observations
Critical deficiency
Major deficiency
Minor/Other deficiency
The close-out meeting

Phase 3: Preparation, Approval & Distribution of the Audit Report
Preparation of the audit report
Report comments
What should not be in the report
Approve and distribute the audit report
Conduct follow up audit

Phase 4: Audit Closure

The System Based Approach
Typical systems
Quality assurance system
Validation / qualification system
Material system
Premises and equipment systems
Packaging and labelling systems
Laboratory control systems (LIMS)
Research and development systems (R&D)
Engineering and maintenance systems
Utilities systems
Warehousing systems

The GMP Auditor
How to be a successful auditor
Professional experience
Knowledge and skills
Audit principles
Management systems and references
Organizational situations
Law and regulatory requirements
Personal suitability
Difficult situations

Examples of Audit Findings
Examples of GMP non-compliance
Quality systems
Facility systems
Equipment systems
Material systems
Production and process control systems
Packaging and labelling
Laboratory control systems
Organizational and personnel
Records and reports
Returned and salvaged products

Final Assessment



Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of FDA Inspection Readiness (GMP Auditing).

This Course is Included in the Following Professional Certification Program(s):

Training Program For Professionals:

FDA Inspection Readiness for GMP Auditors and Professionals

Price: $495.00 (USD)

Professional Certification Program:

GMP Auditor Professional Certification Program

Program ID: AUDPro
Price: $895.00 (USD)

Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further 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 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device 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-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.

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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:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally 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.

Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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