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Home » Pharmaceutical Contamination Control Professional Certification Program

Pharmaceutical Contamination Control Professional Certification Program

Certification Training
 
Rated 4.20/5
10 reviews
Program/Course ID: PCCP
Enrollment Period: 12 months (1 year).
Average Learning Time: ~24 - 36 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Courses: Program includes 16 individual courses (see below).
Digital Badge: Issued upon completion.
Post-nominal Letters: PCCPro™.
Catalog: Contamination Control.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $1995.00 USD  

Document your dedication to compliance, safety, and job performance by earning a professional certification from Biopharma Institute

Biopharma Institute ReviewsTraining Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Description:

Contamination is a serious concern for the pharmaceutical industry. The presence of contaminants such as non-viable particles, micro-organisms and their endotoxins can reduce or even inactivate the therapeutic activity of the drugs and can adversely affect patients taking the contaminated drugs. In this program we will learn about the basics of contamination and the control measures and strategies to prevent pharmaceutical contamination. The program continues to training about cleaning validation within a regulated environment.

Contamination control measures are one of the basic requirements for the manufacture of medicinal products. Pharmaceuticals manufacturing requires a defined and valid system to avoid contamination, as well as a clear disaster strategy to handle any microbiological deviations. In this program we will cover how seriously the FDA takes the potential for contamination of pharmaceutical products, the difference between contamination and cross contamination and the different types of contamination that can be found in a GMP environment.

In this program, we will move on with a discussion on how seriously the FDA takes the potential for contamination of pharmaceutical products. Next, we will define both the terms contamination and cross contamination and describing the different types of contamination including physical, chemical microbiological or viable contaminants.

The porgram moves on to define Quality Risk Management, followed by a discussion on the need for both a risk management team and a risk management plan. We turn our attention to the ICH Q9 QRM process in more detail. We will continue with a closer look at the FDA's focus on risk assessments and European Commission insights on QRM. We will complete this section by covering QRM tool selection and taking a detailed look at the FMEA risk assessment tool for contamination prevention.

The program goes on to take a detailed look at how you can prevent contamination in terms of personnel, facility/building design, HVAC systems, manufacturing processes, area access, cleaning and disinfection, utilities, water, equipment, and materials.

As technology is transforming from conventional clean room concept to barrier technology for aseptic processing and sterility testing, Isolators represent the systems of choice for optimizing product integrity, operator and environment safety. Isolators ensures a greater microbiological safety of the products, but at the same time requires thoughtful knowledge of Isolator technology and basic principles.

This program focuses on the proper use of Restricted Barrier Access Systems (RABS) gloves. The purpose of this course is to provide an understanding of best practice of RABS glove use in a pharmaceutical manufacturing environment. Upon completion of this course, you will have a greater understanding of the following, the role of the RABS gloves within a manufacturing environment, RABS glove physical testing process, RABS glove visual inspection process, maintaining laminar airflow during interventions and RABS glove finger dab sampling.

This program will provide a basic understanding of endotoxin, sources of endotoxin, and the means and methods of controlling endotoxin within a pharmaceutical manufacturing environment. This program focuses on defining the term deviation (nonconformance) and further discusses the expectations of the regulatory bodies in the United States and Europe. The purpose of this section is to provide a general understanding of deviations and how they should be handled when they occur.

The next section of the program defines the types of contamination that can potentially affect pharmaceutical products and includes further discussion specifically about microorganisms. The purpose of this section is to provide an understanding of why ensuring products are free from contaminants is critical where the manufacturing of pharmaceuticals is concerned.

This section continues its focuses on highlighting the sources of contamination within a pharmaceutical manufacturing environment. It will illustrate the ways in which contaminants can find their way into pharmaceutical products during manufacturing, so that special attention can be given to prevention of product contamination.

The program discusses the Vaporized Hydrogen Peroxide (VHP) decontamination process, including a discussion of the three phases of the decontamination process cycle. The purpose of this section is to provide an overview how VHP decontamination fits into the overall objective of contamination control within the pharmaceutical manufacturing environment.

The program introduces best practices for controlling medicinal drug contamination via cleaning and disinfection during the manufacturing process. The purpose of this section is to provide an overview of how cleaning and disinfection helps to address the potential sources of contamination within the pharmaceutical manufacturing environment. It continues by providing an overview of how we address personnel as potential sources of contamination within the pharmaceutical manufacturing environment. Upon completion of this section, you will be able to explain the pharmaceutical contamination control strategies related to the following, personal hygiene & training, best practices for personnel, monitoring methods for personnel and gowning.

This program goes on to describe the best practices for controlling medicinal drug contamination related to the buildings and facilities during the manufacturing process. The purpose of this section is to provide an overview of how we address the buildings and facilities as potential sources of contamination within the pharmaceutical manufacturing environment.


Pharmaceutical Contamination Control Professional Certification Program includes these courses:



Individual Course w/Certificate of Completion:

Contamination Prevention and Control in a GMP Environment

Course ID: ELM-105
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Introduction to Cleaning Validation

Course ID: ELM-601
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Types of Contamination in a GMP Environment

Course ID: ELM-701
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Sources of Contamination in a GMP Environment

Course ID: ELM-702
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Contamination Prevention and Control - Quality Risk Management (QRM)

Course ID: ELM-703
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Contamination Control Strategies in a GMP Environment

Course ID: ELM-704
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

The Basic Principles of Isolator Technology

Course ID: ELM-707
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Restricted Access Barrier Systems (RABS) Glove Training

Course ID: ELM-708
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Introduction to Endotoxin Control

Course ID: ELM-709
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

How Deviations (Non-Conformance) Should be Handled from a Regulatory Perspective

Course ID: ELM-712
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Pharmaceutical Contamination and Microorganisms

Course ID: ELM-713
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Sources of Pharmaceutical Contamination

Course ID: ELM-714
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

The Use of Vaporized Hydrogen Peroxide (VHP) Chambers

Course ID: ELM-715
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Contamination Control Strategies in a GMP Environment: Cleaning and Disinfection

Course ID: ELM-716
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP Contamination Control Strategies - Personnel

Course ID: ELM-717
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP Contamination Control Strategies - Buildings and Facilities

Course ID: ELM-718
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Additional Details:

Certification Requirements: Students must view the entire program and successfully pass online, multiple-choice final assessments for each course within a 180 day/6-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Program enrollees can attempt the final assessments any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a professional certification has been achieved and can be verified immediately from our website using a unique certification ID code. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to validate the training achieved. Digital badges can be displayed on social networking sites, such as LinkedIn.

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale (1-100 students) and large-scale (100+ students) training requests.


Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing 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 course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.


Contact Us:

For additional information on our training programs, to request a quote/invoice, or suggest a course, complete the form below or call toll free in the US/Canada: (888) 4-BIO-LRN. Callers from outside the US can dial +1 (201) 301-8370.

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