GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 1 of 3)
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: Three (3) 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: $199.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 1 of 3)
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
A significant part of the FDA pre-approval process remains inspection actions by the agency to ensure quality, consistency, and safety. Readiness for these inspections is paramount. Having bullet-proof data, documentation, standard operating procedures (SOPs) and other items in place is just part of the puzzle. The people who handle these inspections and all interactions with FDA must be thoroughly screened and selected as well. Since this is likely your "first impression" with FDA, you have no choice but to get it right.
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.
Who should take this course?
Introduction to GMP Auditing
What is an audit?
Why GMP audit?
Safety, business and compliance
Types of GMP audits
Internal audit (Self inspection)
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
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
Beginning the conference room pilot
The ideal combination
Other auditing techniques
General audit findings
The daily wrap up
Classify audit observations
The close-out meeting
Phase 3: Preparation, Approval & Distribution of the Audit Report
Preparation of the audit report
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
Quality assurance system
Validation / qualification system
Premises and equipment systems
Packaging and labelling systems
Laboratory control systems (LIMS)
Research and development systems (R&D)
Engineering and maintenance systems
The GMP Auditor
How to be a successful auditor
Knowledge and skills
Management systems and references
Law and regulatory requirements
Examples of Audit Findings
Examples of GMP non-compliance
Production and process control systems
Packaging and labelling
Laboratory control systems
Organizational and personnel
Records and reports
Returned and salvaged products
This training program has been developed to train employees with Intermediate Knowledge of FDA Inspection Readiness (GMP Auditing).
GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 1 of 3) is included in the following professional certification programs:
FDA Inspection Readiness for GMP Auditors and ProfessionalsCourse ID: FDAINSP
Price: $495.00.00 (USD) | Learn more
GMP Auditor Professional Certification ProgramCourse ID: AUDPro
Price: $895.00.00 (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.|