GxP: Good Practices (GxP) in Drug Development and Manufacturing
|Program/Course ID: GXP01|
Enrollment Period: 6 months.
Average Learning Time: ~30 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1 CPD Credits.
Method of Training: Online, Asynchronous, Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Good Manufacturing Practice (cGMP).
Demonstration: Five (5) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $195.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: GxP: Good Practices (GxP) in Drug Development and Manufacturing
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
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.
An outline of the module's scope and objectives, and notes on terminology.
Drug development and manufacturing:
This session outlines the process of drug development and manufacture, from the discovery of new molecules, through nonclinical studies and clinical trials, to marketing approval application, manufacturing scale-up and quality management, and pharmacovigilance.
Regulation of the industry:
This session outlines the regulation of the industry, introducing the learner to regulatory authorities and other sources of guidance on GMP, GCP and GLP.
Multiple-choice mastery assessment.
Who will benefit from this module?
All entry-level personnel in the pharmaceutical and biotechnology industries.
Good Manufacturing Practice, clinical trials, nonclinical studies, drug safety, regulatory affairs & compliance.
- Outline the process of drug development and manufacture
- Outline the regulation of the industry
- Identify important sources of GxP laws and guidance
Benefits of Training with Biopharma Institute
- Immediate access to courses: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced, asynchronous eLearning: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: Courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: Courses are current with respect to regulations, procedures, and are 3rd party validated and/or accredited.
- Optimized for learning: Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Secure and safe access: Website and LMS provide an encrypted connection, including firewall protection and daily scans for malware, to deliver optimal level of security and performance.
- Flexible final assessments: Assessments 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.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
- Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
- SCORM-compliant courses: Courses can be delivered directly from most corporate Learning Management Systems (LMS).
- Purchase orders (POs): POs are accepted from all companies. You must request an invoice to start the procurement process.
- Reimbursement: Some employers may reimburse their employees for training expenses. Check your company's education reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. Alternatively, purchasing individual courses one at a time is also an option.
- Career advancement: Professional certifications help demonstrate interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer taking points for the interview, and practical knowledge for performing the work.