cGMP: Documentation and Record Keeping
 | Enrollment Period: 6 months. Average Learning Time: ~60 minutes. Additional Resources: Supplemental materials/activities. Method of Training: Online / Self-paced eLearning. Accessibility: 24/7 access to all program materials.Credit Hours: 2 credits. 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 compliance, safety, and job performance by earning a training certification from Biopharma InstituteTraining Program: cGMP: Documentation and Record KeepingTraining 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.  This training program provides a comprehensive overview of current good manufacturing practices, with an emphasis on the role of proper documentation, and how it is used to provide a history of the manufacturing process, from supplier to customer. The course trains on how to develops logs, quality control records, batch processing records, and the requirements of standard operating procedures (SOPs). The course curriculum covers the following sections: quality alerts, the need for documentation, GMP documentation, and proper record-keeping. The training includes a case study to clarify the subject materials, and illustrate in a real-life scenario. Once all course requirements have been satisfied, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate cGMPs and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards. Once all course requirements have been satisfied, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate cGMPs and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards. Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements. Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn. |
Outline:Introduction - Objectives - Reviews and assessment Requirements - What do you think? - What do the GMP rules state? - Regulatory requirements - GMP compliance - Documentation and records - Document features - Document control - Select true or false for each statement - What is required as part of GMP batch documentation? Select all that apply. GMP documentation - What do you think? - What do the GMP rules state? - Types of documentation - Specifications - Inward goods - Manufacturing formula, instructions and batch records - Other production documentation - Quality control (QC) - Fill in the blanks - How must batch records be completed? Record keeping - What do you think? - What do the GMP rules state? - Importance of record keeping - Completing records - Which correction is correct? - Select true or false for each statement Case study - What do you think? - What do the GMP rules state? - Introduction - Identify some documentation issues - Tell the QA Director what you think Conclusion - Summary | Objectives:This module looks at the role of GMP documentation in providing a history of manufacturing from supplier to customer, including the requirements of master instructions, Standard Operating Procedures (SOPs), batch records, quality control records and how to complete GMP records. - Recognise the importance of procedures - Recognise the importance of record keeping - Identify the possible consequences of not completing and certifying GMP documents - Identify how to complete batch records and associated supporting documents | |
cGMP: Documentation and Record Keeping is included in the following professional certification programs:
 | Current Good Manufacturing Practice (cGMP) Professional Certification ProgramCourse ID: GMP001S1Price: $1795.00 (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 which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.
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 (1-100 students) and large-scale (100+ students) training requests.
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.
