GXP: Industry Overview

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Program/Course ID: GXPOV Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials/activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with validation QR barcode.

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2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.

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Outline: INTRODUCTION 1. Course Information 2. Interface Tour 3. Course Overview PIPELINE AND PLAYERS 4. Objectives 5. The Drug Pipeline 6. Regulatory Overview 7. The FDA 8. EMEA 9. Japan 10. Canada 11. Progress Check GxP REGULATIONS 12. Objectives 13. GMP 14. cGMP 15. GLP 16. GCP 17. Progress Check CONCLUSION 18. Summary		Objectives: Describe the steps of the drug development process. Identify the regulatory authorities in the U.S., Europe, Canada, and Japan that oversee the drug development process. Discuss the responsibilities of the regulatory authorities in protecting public health. Discuss the differences and similarities between the EMEA, the FDA, the MHLW, and the HPFB. Provide the historical context behind the formation of regulatory agencies. Define GMP, cGMP, GLP, and GCP. Discuss the history and purpose of the GxP standards. Discuss recent developments in international standardization of regulatory guidelines. Describe the importance of the GxP standards in protecting public health. Quickly access important documentation and links to FDA and EMEA regulations.

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Benefits of Training with Biopharma Institute

Immediate access to courses:	Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:	24/7 access to all course materials and assessments for 12 months.
Open enrollment:	No prior course prerequisites or work experience required.
Expertise:	Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:	Training is current with respect to regulations, procedures, and 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:	Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:	Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:	Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:	Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:	A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:	Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):	POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:	Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:	Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:	Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

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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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Comments: For quotes or invoices please provide the course(s) and number of students.	GXP: Industry Overview