Contamination Prevention and Control in a GMP Environment

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Rated 4.7 / 5 3 reviews Program/Course ID: ELM-105 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: 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).

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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? Course modules Introduction to Contamination Prevention Overview Why the concern over contamination Vaccines Parenteral Medicine Terms explained Review Activity Types of Contamination Overview The FDA What is contamination? What is cross contamination? Types of contamination Microorganisms Size of microorganisms Growing Microbes Different types of microorganisms Growth of microorganisms Rate of growth of bacteria Sources of Contamination Overview Where does contamination come from? Sources of contamination Personnel Sources of viable contamination Human hands Skin Proper hand washing Building and facility Equipment Materials Manufacturing process HVAC systems Modes of cross contamination Review Activity Quality Risk Management Overview QRM defined QRM team for contamination prevention ICH Q9 Quality Risk Management - Part 1 ICH Q9 Quality Risk Management - Part 2 FDA focus on risk assessments QRM European Commission Insight Quality risk management tool selection FMEA - Contamination preventation FMEA example Contamination Control Strategies Overview Control strategies Personnel - Part 1 Personnel - Part 2 Monitoring methods - people Gowning Facility building design - Part 1 Facility building design - Part 2 Facility building design - Part 3 Aseptic facilities Airlocks Pressure differentials HEPA Filters Laminar air flow Heating ventilation and air conditioning (HVAC) system Manufacturing process Access to areas Cleaning and disinfection - Part 1 Cleaning and disinfection - Part 2 Chemical agents Different type of chemical agents How to use the chemical agent Utilities Water Sterilization Sterile equipment Equipment - Part 1 Equipment - Part 2 Materials Conclusion Final Assessment Certification		Objectives: Skill Level: Basic This training program has been developed to train employees with Basic Knowledge of Contamination Control and Aseptic Techniques.

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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.	Contamination Prevention and Control in a GMP Environment