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: Pharmaceutical CAPAs
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment.
This online training program describes corrective and preventive actions (CAPAs), and how good manufacturing practices can be applied to eliminate causes of non-conformities or other undesirable situations. The training program enables the students to interpret and identify the requirements of a pharmaceutical CAPA system. As a fundamental management tool, CAPA is integral to the effectiveness of a quality management system. The objectives of this course are to teach the requirements of ICH Q10- PQS (Pharmaceutical Quality System), describe escalation and tracking processes in a CAPA system, explain the importance of investigation and risk assessment, list a CAPA system's critical elements, explore the different processes and phases of a good CAPA system, and identify a CAPA system's regulatory requirements.
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.
- Reviews and assessment
- PQS model
- Key PQS elements
- CAPA definitions
- What do the GMP rules state?
- Match the actions
- Compliant CAPA systems
- CAPA phases
- Closed loop CAPA system
- Select all that apply to a compliant CAPA system
- What determines whether a CAPA is required or not?
- Fill in the blanks
CAPA system elements
- Sources of data
- Risk management
- Risk assessment
CAPA system elements (continued)
- CAPA request
- Corrective action
- Preventive action
- Verification and close-out
- CAPA report
- True or false?
- Why is risk management important to CAPA?
- Put these CAPA steps in order
- Which action is immediate when a problem arises?
Root Cause Analysis (RCA)
- Example scenario
- Root Cause Analysis (RCA)
- Investigation tools
- When to conduct RCA and CAPA
- What must be defined before a RCA?
- Match the terms
Tracking and escalation
- Progress tracking and escalation
- CAPA system effectiveness
This module addresses identification and interpretation of the requirements of a Corrective and Preventive Action (CAPA) system. CAPA is a fundamental management tool that is integral to an effective Pharmaceutical Quality System (PQS).
- identify regulatory requirements of CAPA
- list the phases and processes of a successful CAPA system
- explain a CAPA system's critical elements
- explain the importance of documentation
- describe tracking and escalation processes
- recognize ICH Q10 requirements of CAPA, including root cause and risk assessment
cGMP: Pharmaceutical CAPAs is included in the following professional certification programs:
Price: $1795.00 (USD) | Learn more
Price: $1895.00 (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.