GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 3 of 3)
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Price: $199.00 USD  |
Download Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.Training Program: GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 3 of 3)Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  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 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'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 promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode. Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr. 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. |
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 | Objectives:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of FDA Inspection Readiness (GMP Auditing). | |
This Course is Included in the Following Professional Certification Program(s):
 | FDA Inspection Readiness for GMP Auditors and ProfessionalsCourse ID: FDAINSPPrice: $495.00 (USD) |
 | GMP Auditor Professional Certification ProgramProgram ID: AUDProPrice: $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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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: | Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode. |
| Verification of training: | Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally 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. |
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