Enrollment Period: 12 months (1 year).
Average Learning Time: ~24 - 36 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online, Asynchronous, Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Courses: Program includes 16 individual courses (see courses).
Outline/Syllabus: See individual course pages for outlines.
Digital Badge: Issued upon completion.
Post-nominal Letters: PCCPro™.
Catalog: Contamination Control.
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).
Price: $1995.00 USD
Document your dedication to compliance, safety, and job performance by earning a professional certification.Training Provided By: Biopharma Institute
Outline/Syllabus: See individual course pages for outline.
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. Furthermore, contaminates 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 moves on to further describe 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 validated system to avoid contamination, as well as a clear disaster strategy to handle any microbiological deviations. In this Pharmaceutical Contamination Control Professional Certification 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 to define both the terms contamination and cross contamination, and further describe the different types of contamination, including physical, chemical microbiological or viable contaminants.The program 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 detail, and continue forward with a closer look at the FDA's focus on risk assessments and European Commission insights on the 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 and operator/environmental safety. Isolators ensures a greater microbiological safety of the products, but at the same time it requires thoughtful knowledge of Isolator technology and basic principles.This program also offers a focus on the proper use of Restricted Barrier Access Systems (RABS) gloves. The purpose of this section is to provide an understanding of best practice of RABS glove use in a pharmaceutical manufacturing environment. Upon completion of this section, students 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 moves forward to provide a basic understanding of endotoxin, sources of endotoxin, and the means and methods of controlling endotoxin within a pharmaceutical manufacturing environment.This program further focuses on defining the term deviation (nonconformance) and 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 a 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 additionally 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, students 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 16 individual courses:
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessments for each course within a 12-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements.
Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity or recertification period for employee compliance training would be determined by those responsible for managing quality within the company.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into any program or course. Students may 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 ID code located on the certificate. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format.
Additionally, once the student has completed the professional certification program, a digital badge is issued. The digital badge documents all the courses taken and completed within the program, to further validate the student's achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Badgr, and others, to display the accomplishment.
Benefits of Being Certified from Biopharma Institute: Throughout the online training courses students will be engaging in active learning using interactive eLearning modules developed to promote the retaining of key knowledge. Furthermore, students will be provided with access to references, the regulatory guidelines, case studies, and other important information necessary to gain a professional understanding for the discipline.
Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with attaining their training requirements. Our courses are developed by subject matter experts (SMEs) in the topic of study and have all been validated and/or accredited by a neutral 3rd party. Biopharma Institute certifications are recognized by regulators and companies in a wide range of industries around the world.
Biopharma Institute has training solutions which are customizable to any organization's training needs. We aim to provide only the highest quality of training, which is current, engaging, effective, and easy to navigate.
Today, Biopharma Institute has over 200+ courses in its catalog. These courses train on clinical trials, drug manufacturing, regulatory affairs, validation systems, drug safety, pharmacovigilance, good laboratory practice, and data integrity; all within the medical device, clinical research, and pharmaceutical industries.
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 and large-scale training requests.
Benefits of Training with Biopharma Institute
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
- Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
- Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
- Purchase orders (POs): If issuing 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.
- Reimbursement: Some employers may reimburse for training expenses. Check 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.
- Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
- Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.