Student Login |


Sunday, June 20, 2021
Home » GDocP: Corrective and Preventive Actions (CAPA)

GDocP: Corrective and Preventive Actions (CAPA) (ELM-117)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Good Documentation Practices.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: GDocP: Corrective and Preventive Actions (CAPA)
Training 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. Biopharma Institute ReviewsIn this course we will discuss corrective and preventive action also called CAPA which are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice (GMP), and numerous ISO business standards that is critical to an organizations continuous improvement.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


GDocP: Corrective and Preventive Actions (CAPA) course is included in the following Professional Certification Programs:



Good Documentation Practices (GDocP) Professional Certification: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

COURSE OUTLINE:


Introduction
Agenda
Regulatory
Regulatory explanation
Only about compliance?
The Basics: CA
The Basics: PA
Key concepts
Systemic issues
Non-systemic issues
Systemic issues - product examples
Systemic issues - process examples

Industry
Industry [Non]Compliance
Process Requirements
Process Requirements: FDA
Process Requirements: ISO 13485

Sources
Sources
Risk: Helping you manage
The process
First things first: understand
Containment
Scope analysis: Food for thought

Root Cause Analysis
Root cause analysis (definition)
Root cause analysis - why?
Root cause analysis: toolbox
Root cause analysis: example
Root cause analysis: example (5 Whys)
The results
Root cause analysis: Major tripping point
Root cause analysis: final thoughts

Actions
Action
Actions: more than just 'To Do'?
Actions: A Tripping Point

Review
Review
Management Review Input
Actions > Effectiveness > Transition

Effectiveness
Effectiveness: expectations
Effectiveness
Effectiveness: simple?
Actions / effectiveness: example 1
Actions / effectiveness: example 2
Inspection / audit focus
Take-aways
The future
Conclusion

Conclusion


Final Exam


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of Good Documentation Practices (GDocP).

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.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

Information Request / Suggest a Course Form:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us with as much detail as possible about your training project):