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Home » GMP: FDA Inspection Readiness - Part 1

GMP: FDA Inspection Readiness - Part 1

Certification TrainingProgram/Course ID: ELM-122
Enrollment Period: 3 months.
Allocated Learning Time: ~45 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 Manufacturing Practice (cGMP).
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: GMP: FDA Inspection Readiness - Part 1
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 ReviewsA 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 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

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
Interviews
Inspections
Records review
Observations
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

Conclusion
Final Assessment

Certification

Objectives:


Skill Level:
Intermediate

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

GMP: FDA Inspection Readiness - Part 1 is Included in the Following Professional Certification Program(s):



 Training Program For Professionals: 
FDA Inspection Readiness for Professionals
Course ID: FDAINSP
Price: $495.00 (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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