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cGMP: Warehouse for Pharmaceuticals

Certification Training
 
Rated 4.09/5
11 reviews
Program/Course ID: GMP02
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 quality, compliance, safety, and job performance by earning a training certification.

Training Program: cGMP: Warehouse for Pharmaceuticals
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon enrollment.

Description:
Biopharma Institute Reviews

The GMP for the Warehouse training program provides an overview and discussion of the role current good manufacturing practices has in the warehouse; and offers an emphasis in receipts, issues, storage, and distribution. The course covers an introduction to GMP, and includes sections describing the role of the warehouse, cGMP guidelines which pertain to the warehouse rules, receipts, and issues to manufacturing. The course also includes details regarding finished product releases, handling returns, proper documentation practices, and a wrap-up summary.

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 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
- GMP for the warehouse
- GDP and GWP
- Objectives
- Reviews and assessment

Role of the warehouse
- What do you think?
- What do the GMP rules state?
- GMP for the warehouse
- What comes into the warehouse?
- Typical warehouse layout
- Repacking
- Personnel and training
- Preventing contamination and deterioration
- Preventing mix-ups
- Segregation
- In the BOM or not in the BOM?

GMP rules for the warehouse
- What do you think?
- What do the GMP rules state?
- General GMP rules
- Housekeeping
- Unique Identification
- Status labels
- Product labels
- Storage requirements
- Protecting materials
- Pest control
- Air control
- Temperature control
- Cold storage
- Other sensitive materials
- Enter the missing words to complete this housekeeping phrase.
- Select true or false for each statement
- Match the label information

Receipt and issue to manufacturing
- What do you think?
- What do the GMP rules state?
- Approving suppliers
- 5-step process (receipt to production)
- Receiving starting materials
- Material Safety Data Sheet (MSDS)
- Receiving printed materials
- Storing materials
- Issue of materials
- Stock rotation
- Defective and expired materials
- MSDS
- what is it good for?
- True or false?
- When does direct control over product quality begin?

Finished product and handling returns
- What do you think?
- What do the GMP rules state?
- Overview
- Release process
- Picking, packing and dispatching
- Transportation and distribution
- Customer returns
- Managing recalls
- Ordering the process
- Select true or false for each statement

Documentation
- What do you think?
- What do the GMP rules state?
- Traceability
- Purchase Orders (POs)
- Inward Goods
- Internal audit / Self-inspection

Conclusion
- Regulatory inspection findings
- Summary

Objectives:


This module provides an overview of how GMP applies to the warehouse with respect to receipt, storage, issue and distribution.


- Explain the role of the warehouse
- List the GMP procedures needed in the warehouse to control incoming goods
- Identify the GMP requirements of handling starting materials and finished products in the warehouse
- Recognize the GMP issues surrounding release of finished products to the marketplace
- Recognize issues around transport of goods to and from the public
- Recognize how to handle returns
- Identify the different documentation needed in the warehouse

cGMP: Warehouse for Pharmaceuticals 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

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.
  • Optimized for learning: Courses include voice-overs, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
  • 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.
  • Purchase orders (POs): If a PO is required by your company, request an invoice to start the procurement process. we accept all purchase orders.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Tuition reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
  • 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.
  • 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: 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 requirements have been fulfilled.


Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.