GMP: FDA Inspection Readiness - Part 3 (ELM-124)
 | 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 3Training 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.  The 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 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 3 course is included in the following Professional Certification Programs:
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COURSE 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 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 | COURSE OBJECTIVES:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of FDA Inspection Readiness (GMP Auditing). | |
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