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cGMP: An Introduction to Good Manufacturing Practice (GMP01)

Certification Training
 
Rated 4.08/5
12 reviews
Method of Training: Online / Self-paced eLearning.
Credit Hours: 2 credits.
Duration: ~2 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Good Manufacturing Practice (cGMP).
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.

Training Program: cGMP: An Introduction to Good Manufacturing Practice
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 Reviews

This GMP course includes an introduction to current good manufacturing practices (cGMPs), information on maintaining product quality, the scope of GMP rules, a section on cleaning and sanitation, a look into proper documentation, and concludes with a summary. The course will explore a list of essential packaging and production controls, review of guidelines describing the proper way to execute GMP records, examines the GMP personal hygiene requirements, clarifies the four key product quality attributes, describes the purpose of GMP codes and regulations, and offers explanations of why companies implement GMP.

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.

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.

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, interactive, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our training programs cater to both small-scale (2-100 students) and large-scale (100+ students) training requests. 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 our training solutions are customizable to any organization's training needs.



cGMP: An Introduction to Good Manufacturing Practice course is included in the following Professional Certification Programs:



 Professional Certification Program: 
Current Good Manufacturing Practice (cGMP) Professional Certification Program
Course ID: GMP001S1
Price: $1795.00 (USD) | Learn more

COURSE OUTLINE:


Introduction
- What is GMP?
- Objectives
- Reviews and assessment
- Events that have shaped GMP
- Evolution of GMP
- Introduction to GMP codes
- GMP regulatory bodies (EMA, FDA, Health Canada, Medsafe, MHRA, PIC/S, TGA, WHO)
- Specific GMPs (FDA, EU, PIC/S)
- What is GxP?
- Why are GMPs important? Select all that apply.
- GMP stands for?
- Match the GMP regulatory body to the region Quality
- What do you think?
- What do the GMP rules state?
- What is product quality?
- Purity
- Identity
- Effectiveness
- Safety
- Why does quality matter?
- Pharmaceutical Quality System (PQS)
- Select true or false for each statement
- Fill in the blanks

Scope of GMP rules
- What do you think?
- What do the GMP rules state?
- Scope by EU and PIC/S Guide to GMP chapters

Scope of GMP rules (continued)
- Comparing GMPs of the EU and PIC/S with the FDA
- Personnel and training
- Premises
- Equipment
- Manufacturing areas
- Manufacturing controls
- Self inspection / internal audit
- How much is true?
- What's the impact?
- Why are self inspections needed?

Cleaning, hygiene and gowning
- What do you think?
- What do the GMP rules state?
- Housekeeping
- Cleaning and sanitation
- Personal hygiene and gowning
- Topic review

Documentation
- What do you think?
- What do the GMP rules state?
- Proof of product quality
- Manufacturing records
- Rules for completing records
- Which correction is correct?
- Electronic data
- Data integrity
- True or false?
- Select all that apply

Conclusion
- Summary

COURSE OBJECTIVES:


This module provides a solid introduction to control and management of manufacturing and quality of pharmaceutical products.


- Explain why your company has implemented GMP
- State the purpose of GMP regulations
- State the four key product quality attributes
- State the requirements for personal hygiene
- Describe the correct way to complete records
- List the essential production and packaging controls

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.

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