GMP: FDA Inspection Readiness - Part 3 of 3
 | Enrollment Period: 6 months. Average 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. Catalog: Good Manufacturing Practice (cGMP).Demonstration: Five (5) free trial courses are available. Final Assessment: Multiple choice; unlimited attempts. Certificate: PDF with validation code (See sample). Price: $199.00 USD |
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: GMP: FDA Inspection Readiness - Part 3 of 3Training 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 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements. 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. 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 instantaneously launched and made available to the student in a PDF format upon completion. Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr. |
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). | |
GMP: FDA Inspection Readiness - Part 3 of 3 is included in the following professional certification programs:
 | FDA Inspection Readiness for ProfessionalsCourse ID: FDAINSPPrice: $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 validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They 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 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.
Group Training for Employees: 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.
Benefits of Training with Biopharma Institute
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
- Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
- Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
- Purchase orders (POs): If issuing 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.
- Reimbursement: Some employers may reimburse for training expenses. Check 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.
- Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
- Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
