Contamination Control (PMF101)

Description

Contamination Control Training (PMF101)

Contamination Control eLearning Course (PMF101): Part 1 in the Pharmaceutical Manufacturing Fundamentals (PMF) Series

After completing this Contamination Control training course (online), learners will gain an understanding of:

• Basic microbiology in relation to risks of contamination
• How contamination risks impact the design of manufacturing processes, facilities and procedures
• Contamination controls
• Relevant quality control measures and contamination prevention measures in GMP environments

Pharmaceutical Manufacturing Fundamentals: Education

This Pharmaceutical Manufacturing Fundamentals eLearning course “Contamination Control” (PMF101) is the first (1st) of four (4) individual courses in the Pharmaceutical Industry education series.

• These four PMF courses can be purchased and completed individually (each course provides a unique Certificate of Completion after successful completion of the online assessment)
• However, they are recommended to be completed as part of the 4-part eLearning Training Package designed for industry professionals and pharmaceutical industry job applicants.
• It is recommended that you complete all 4 courses in sequence, along with other relevant GMP compliance training.

NOTE: Industry training for regulatory compliance is not a replacement for your onsite training and product-specific training. However, it can help you better understand regulatory compliance requirements and contamination prevention in GMP facilities.

PMF101 in the Pharmaceutical Manufacturing Fundamentals education series covers Contamination Control.

• This self-paced education course will help you gain a basic understanding of the microbiology that underpins the design of processes, facilities and procedures for contamination control in the pharmaceutical manufacturing and/or medical device sectors.
• Topics include different types of potential contaminants (bacteria, yeasts, moulds, endotoxins, etc) and different contamination control methods used in the pharmaceutical industry to control contamination risks.

Contamination Control Methods in a Pharmaceutical Manufacturing (GMP) Facility

In this first of four PMF eLearning courses produced by the GMP consultant experts at PharmOut Pty Ltd, we’ll explore:

• Microbiology of bacteria, sources of microbial contamination and sterility concepts and sterility quality assurance
• Contamination control, including cleaning and sterilisation methods
• Aseptic Techniques and Facility Design

After completing this course, you should complete PMF102 – HVAC, followed by the remaining two courses in this Pharmaceutical Manufacturing Fundamentals education series.

About this course

• One user per order.
• All rights reserved.
• You can start immediately upon completing your purchase online.

Read the eLearning Course FAQs. 

Contamination Control and GMP regulations

This Contamination Control training course is best completed as part of the 4-part Pharmaceutical Manufacturing Fundamentals eLearning series.

Review the Pharmaceutical Manufacturing Fundamentals education series (online courses).

Who should complete the PMF series?

• The 4 PMF Courses are suitable as Employee GMP Induction Training, GMP Refresher training, and/or upskilling training.
• These courses are suitable for a variety of pharmaceutical industry employees and/or medical device industry employees.

The PMF Series courses are suitable for:

• Engineers and Quality Management Personnel
• New employees and existing employees
• Operations personnel, system designers, and validation engineers
• Facility Architects
• A wide range of personnel and contractor roles in GMP compliance sectors
• Companies involved with providing cleaning services, source materials, raw materials/packaging or labelling products, equipment, and/or services to the Pharmaceutical Manufacturing or Medical Device sectors

Contamination Control Essentials in an eLearning Course Format

PMF101 (Contamination Control) is the first of four eLearning modules in the recently released PMF Training Series.

• It can be taken as a stand-alone course or as part of a more comprehensive series of four (4) modules
• It should be completed along with other product-relevant GMP compliance training modules specific to the industry, product type, and distribution region (Regulatory Authority/Competent Authority).
• View GMP course bundles per industry or continue reading for more on the Pharmaceuticals Manufacturing Fundamentals course (Contamination Control/PMF101 – Module 1 of 4 in the PMF Series).

Contamination Control Course Agenda

This eLearning course covering Contamination Control (Contamination Prevention) in pharmaceutical industry manufacturing environments has 3 parts.

These 3 parts describing regulatory requirements and expectations for pharmaceutical industry contamination control include:

• The microbiology of  bacteria, sources of microbial contamination and sterility concepts and sterility quality assurance
• Contamination control requirements in Pharmaceutical Manufacturing facilities, including cleaning and sterilisation requirements
• Aseptic techniques and facility designs (engineering/design considerations)

How to complete this PMF101 eLearning course

The course can be taken as a stand-alone course but is recommended to be completed as part of the Pharmaceutical Manufacturing Fundamentals (PMF) online learning series of four (4) individual GMP training modules.

• To complete this course, first, complete your purchase online, then search your email folders for your login information.
• You will need internet access to access the course and complete the training.
• While you can typically use a mobile phone to access this course, it is best completed on a laptop or other device with an adequate screen and functionality.

Are there prerequisites to this pharmaceutical manufacturing industry eLearning course?

• There are no formal prerequisites for this PMF orientation course although other relevant GMP courses will be helpful.
• Additionally, onsite custom training programs and adequate Supervision are required for personnel working in these sectors.

Recommendations for supplemental GMP regulations compliance training

While there are no formally required pre-requisites for completing this training module in contamination prevention (pharmaceutical industry/medical device industry), it is helpful to:

• Have at least a basic understanding of basic GMP principles and GxP compliance regulations before embarking on this course or other modules in the PMF series, such as covered in GMP01 and GMP02 and the 10 Golden Rules of GMP (visit the online GMP education topics section).
• Good Recordkeeping practice training is also recommended for all employees.
• Note: Regarding good recordkeeping practice/good documentation practice, gaps in recordkeeping are often cited in warning letters from Regulatory Authorities such as the TGA, MHRA and FDA.

You can take these additional GMP compliance courses before OR AFTER you complete the Pharmaceutical Manufacturing Fundamentals training course.

Gain your online GMP Course Certificates

Upon successful completion of the online Final Assessment of this module, you’ll be able to download and print a Certificate of Completion for your Pharmaceutical Manufacturing Fundamentals course topic. When you complete the entire series, you’ll have gained 4 PMF training Certificates of Completion for your records and pharmaceutical industry job applications.

• To gain your Certificate, order and pay for the course online (add to cart, above), then search your email for your login information (search all folders).
• You’ll have 12 months’ access to the course from your date of purchase.
• Upon reviewing the materials and successfully completing the online Final Assessment, you’ll gain a GMP/PMF Course Certificate of Completion to download, print or save.
• Send this Certificate to your Supervisor, Personnel Management department, and/or attach this Certificate to your CV when applying for job openings in the Pharmaceutical Sector.