Method of Training: Online / Self-paced eLearning.Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Good Manufacturing Practice (cGMP).
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.Training Program: GMP: FDA Inspection Readiness - Part 2
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment. Periodically auditing for Good Manufacturing Practice (GMP) observance is a regulatory requirement. This not only involves a methodical understanding of the regulations, but also an insight into how they are being applied. This course gives you detailed information on various aspects of carrying out an audit efficiently and also helps you to improve your skill set to ensure you get the best out of each audit. Remember, effective auditing is an acquired skill, one that requires lots of hard work!
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.
GMP: FDA Inspection Readiness - Part 2 course is included in the following Professional Certification Programs:
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).
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.