GMP: Good Manufacturing Practices

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Rated 4.7 / 5 3 reviews Program/Course ID: ELM-103 Enrollment Period: 12 months. Average Learning Time: ~60 minutes. Additional Resources: Supplemental materials/activities. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Credit Hours: 3 credits. Demonstration: Three (3) 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).

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NOTE: This course has been updated.
A newer version may be available in our catalog.

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Outline: Introduction Overview Learning objectives Who should take this course? Module overview The Starting Line Overview What is GMP? What is cGMP? World Health Organization (WHO) Why GMP? Cases From History Overview Cases from history 1930 - Lubeck - BCG Vaccine 1938 - Sulphanilamide 1940 - Contaminated Caps - Lambert 1955 - Polio Vaccine 1962 - Thalidomide Why GMP is so Important? GMP Regulations Overview GMP Regulations & Guidelines GMP's in Different Countries WHO ICH EMEA MHRA USFDA GMP concept What aspects of manufacturing does cGMP cover? Review activity Pharmaceutical Quality System (PQS) / Quality Management System (QMS) Overview What is Quality Management? Standard Operating Procedures (SOP) Quality Objective GMP as a part of Quality Assurance Requirements for an effective QA program ICH Q10 Life Cycle Phases of GMP Premises Overview Premises Production Areas Changing Rooms Storage Areas Quality Control Areas Personnel Overview Personnel General Principles Staff Product Contact Requirements Grades A,B,C & D Personal Hygiene General considerations for manufacturing areas Review activity Changes to Equipment Overview Equipment Balances Utilities Documentation Change control Qualification & Validation Overview Definitions Qualification Vs Validation Risk Assessment Types of Validation Documentation Complaints and Product Recalls Overview Complaints and product recalls Classification of defects - critical Classification of defects - major Classification of defects - minor Product recall procedures Self-Inspection Production Practices Quality Control		Objectives: Skill Level: Basic This training program has been developed to train employees with Basic Knowledge of Good Manufacturing Practices (cGMP) .

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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:	Certificate of completion is instantly available once requirements have been fulfilled.
Verification of training:	Certificates verifiable online with digital badges 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.	GMP: Good Manufacturing Practices