Equipment Validation: Introduction to Risk Based Equipment Qualification
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2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline:Introduction Course Introduction Course Overview Course Objectives Module 1 The Starting Line Terms Explained Benefits of Equipment Qualification US Regulatory Compliance European Regulations ICH Q9 Module 2 Equipment Qualification Planning Equipment Qualification Process Qualification Planning Master Validation Plans Qualification Need Assessment Risk Classification Direct Impact Indirect Impact No Impact Impact Based Qualification Activities Direct Impact Documentation Indirect Impact Documentation Master Validation Plan Listing Module 3 Risk Tools User Requirement Specification (URS) Risk Assessment What is Risk? What is Risk Management? Risk Management Tools Risk Management Tools Cont'd HACCP - Hazard Analysis and Critical Control Points HAZOP - Hazard Operability Analysis FTA - Fault Tree Analysis PHA - Preliminary Hazard Analysis Quality Risk Management Tool Selection Failure Mode Effect Analysis (FMEA) So What is Expected During Regulatory Inspections? Step 1: Risk Detection/Identification Step 2 is Risk Analysis Step 3 is Risk Evaluation Risk Evaluation Methods - Quantitative Method Risk Evaluation Methods - Qualitative Method The Hybrid Method Severity & Probability Risk Control Risk Assessment Table Risk Communication Risk Review Module 4 Qualification Phases FAT (Factory Acceptance Testing) SAT (Site Acceptance Testing) Equipment Design Qualification (DQ) DQ Review Documents Installation Qualification (IQ) Documents to Analyze During IQ Review Pre-conditions for IQ Execution Equipment Operational Qualification (OQ) OQ and Commissioning Pre-Conditions for OQ Execution: Equipment Performance Qualification (PQ) Pre-conditions for PQ execution: Requalification Change Control Conclusion Final Exam Certification | Objectives:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of Equipment Qualification. | |
This Course is Included in the Following Professional Certification Program(s):
Equipment Qualification for ProfessionalsCourse ID: EQPROPrice: $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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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. |
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