Pharmaceutical Contamination Control Professional Certification Program
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Price: $1995.00 USD |
Download Document your dedication to compliance, safety, and job performance by earning a professional certification. Training Provided By: Biopharma InstituteWebsite: https://www.biopharmainstitute.com Outline/Syllabus: See individual course pages for outline. Description: Training on contamination control for those manufacturing pharmaceuticals is very important because contamination is a serious concern for the 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.
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 | Introduction to Cleaning ValidationCourse ID: ELM-601Duration: 60 minutes (0.1 CPD Credits) Price: Included |
 | Types of Contamination in a GMP EnvironmentCourse ID: ELM-701Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | Sources of Contamination in a GMP EnvironmentCourse ID: ELM-702Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | Contamination Prevention and Control - Quality Risk Management (QRM)Course ID: ELM-703Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | Contamination Control Strategies in a GMP EnvironmentCourse ID: ELM-704Duration: 60 minutes (0.1 CPD Credits) Price: Included |
 | The Basic Principles of Isolator TechnologyCourse ID: ELM-707Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | Restricted Access Barrier Systems (RABS) Glove TrainingCourse ID: ELM-708Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | Introduction to Endotoxin ControlCourse ID: ELM-709Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | How Deviations (Non-Conformance) Should be Handled from a Regulatory PerspectiveCourse ID: ELM-712Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | Pharmaceutical Contamination and MicroorganismsCourse ID: ELM-713Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | Sources of Pharmaceutical ContaminationCourse ID: ELM-714Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | The Use of Vaporized Hydrogen Peroxide (VHP) ChambersCourse ID: ELM-715Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | Contamination Control Strategies in a GMP Environment: Cleaning and DisinfectionCourse ID: ELM-716Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | GMP Contamination Control Strategies - PersonnelCourse ID: ELM-717Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | GMP Contamination Control Strategies - Buildings and FacilitiesCourse ID: ELM-718Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | GMP: Good Manufacturing Practices - Good Practices and Quality ControlCourse ID: ELM-204Duration: 30 minutes (0.1 CPD Credits) Price: Included |
Additional Information:
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment for each course within a 12-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment 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. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode. Furthermore, a digital badge is also 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 accomplishments.
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.
Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device 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-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
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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: | Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode. |
| Verification of training: | Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally 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. |
Have Questions? Contact Us:
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.
