Contents:

- Introduction to the Pharmaceutical Industry Introduces the Pharmaceutical Industry, what it manufactures, and the typical departments found in a pharmaceutical plant. - Introduction to GMP for Finished Dose What GMP is, why it is important for safe guarding the end user, and the laws that govern it. - Regulatory Agencies Who regulates the pharmaceutical industry, how new drugs are approved, types of regulatory inspections, and the role of employees in inspections. - Finished Dose Contamination Prevention How finished dose products can be contaminated during production and how to minimize contamination through the use of PPE and good sanitation habits. - Dress Codes for Finished Dose Manufacture Explains dress codes and why they exist in the finished dose pharmaceutical industry. Examples of the different types of clothing required for the different areas within a pharmaceutical plant are shown. - GMP Goals Describes the GMP responsibilities of employers and employees and the importance of procedures and records.

Summary:

A modern aseptic manufacturing facility faces a variety of regulatory and operational challenges including: - Working in compliance with current industry GMP (Good Manufacturing Practice) regulations - Reducing operating costs while maintaining product quality - Increasing productivity and reducing levels of waste and rework These challenges cannot be successfully met without the input of a competent, well-trained workforce. "Persons engaged in manufacturing, processing or packing of drug and device products do not have adequate training to enable those persons to perform the assigned functions." - extract from FDA Warning Letter to Aseptic Manufacturer – To achieve and maintain product sterility, operators involved in aseptic manufacturing must be trained in the principles of aseptic technique. Most importantly, given the nature of aseptic manufacturing and the high risk of contamination, operators must receive this training before being allowed to enter an aseptic area. "Essential GMP for Finished Dose Operators (Certified)" is part of the EssentialOperator™ for Aseptic facilities e-Learning curriculum which is specially designed for operators involved in aseptic manufacturing. It provides critical knowledge in key areas such basic microbiology, isolators, cleanroom CGMP, gowning, sterilization processes, and health and safety issues. Accessed via the Internet or your company's intranet, each EssentialOperator™ course is a multimedia learning experience that combines text, graphics, animation and audio to present critical knowledge in an engaging and interactive way. Equipped with such knowledge, the transition from trainee to competent operator is made smoother and more efficient. Standard Operating Procedures (SOPs), with their own particular industry jargon, become easier to understand. On-the-Job Training becomes more effective as trainees comprehend what they see and hear. A thorough grasp of the principles of aseptic manufacturing will contribute to improved operational efficiencies and a reduction in waste and rework. "Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions." - extract from Code of Federal Regulations 21 CFR Part 211 Current Good Manufacturing Practice For Finished Pharmaceuticals – Further Information The flexibility of our Courseware design allows you to pick any number of Lessons from any part of the Lesson Library to develop your own customized training Courses. There are over 100 Lessons in our catalog. Each Lesson will require the Trainee to spend approximately 30 minutes to review the content and about 15 minutes to complete the assessment. Each month new Lessons are added to our Lesson Library. Lessons are categorized for the following industries: - Pharmaceutical Finished Dose Facility - Active Pharmaceutical Industry / Bulk Facility - Biotechnology Facility - Medical Device Facility Our lessons provide a total compliance training management solution for the regulated healthcare and pharmaceutical industries. We deliver solutions that address the major management issues resulting from increased government regulations. We help our clients to manage risk and limit exposure to the adverse effects of: - Stricter Executive Liability - Larger fines - Increases in the numbers of Warning Letters - More frequent inspections & prosecutions - Increased risk of non-compliance, and - Greater regulatory emphasis on Training Systems and documentary evidence Our solutions are based on an understanding of your business needs. Our approach to training improves employee performance, regulatory compliance and operational effectiveness. Our e-Learning Courseware provides the Pharmaceutical and Regulated Industries with training solutions designed to help you achieve and retain industry and regulatory compliance standards. Our teams of industry subject matter experts understand and anticipate your training needs in line with emerging regulations. We provide content that is both technically accurate and current to industry practices and regulations. Course delivery includes a wide range of options, from a standalone PC, to local area network, to delivery over the Internet or corporate Intranet. Our Lesson Library is job-related and competency-based. This means that you can build a customized training program that is unique for each job function in your organization chart. Assessments are included with each Lesson and are customizable, enabling the trainer to determine the pass level and to evaluate trainee comprehension. Our Courseware installation can be validated and comes with complete System Documentation (including User Manuals, a Validation Plan and Installation and Operational Protocols). Our Mission is to provide our customers with a business solution based on a stimulating, effective, and compliant learning environment. Our Off-the-shelf programs are validated and frequently updated to reflect industry and regulatory developments. Courseware lessons are job focused, competency based, and offer test sections to assess trainee understanding. 2-D & 3-D graphic modeling are used in the products for enhanced interactive and visual learning experiences. Issues with Traditional Approaches to Learning: The feedback on traditional training initiatives clearly indicates that there are many challenges to be addressed to introduce and maintain an effective training policy. Typically, organizations report the following general issues that must be addressed from the outset in order to ensure success at the planning stage: - Standard courses that are designed for distribution to large numbers, but do not meet individual learner needs - Courses are too long, students are bored / tired - Low attendance rates among students Our course designers have studied this feedback and have built our Courseware around a number of principles that address these issues. - Learning must enhance performance. Learning must be results-driven, and performance enhancing for both the individual and the organization. This is achieved by ensuring that the job skills are aligned to the department function during the needs analysis. - Courseware should be flexible. Training Lessons should be capable of delivery in "bite sized chunks" that can be taken anytime, anywhere and at the convenience of the learner. - Learning should be customizable. Learning should be focused on individual needs. Our course content can be combined in different ways to build courses to meet individual needs. Our competency model provides a building block approach to profiling the skills necessary for an individual job function. - Learning must be engaging. To be effective, learning needs to be stimulating and interesting. This ensures that the learner will be engaged with the content and will improve retention rates. - Learning must be targeted and measured. Learning should focus on skills that will help the learner improve their performance and position in the organization. e-Learning can measure where an employee is compared to the desired competency level for their function. This helps provide quality feedback to employees. e-Learning or electronic learning is the future of learning for Regulated Industries. Advances in information technology and the rapid proliferation of the Internet have made anywhere, anytime learning a reality. e-Learning involves electronic delivery and assimilation of information or content over a network such as the Internet, an Intranet or a Local Area Network. Why e-Learning? As part of an overall training solution, e-learning is attractive for a number of reasons: - It delivers many of the benefits of instructor led training without the associated costs of tuition, travel, administration, and time away from the job. - It is self-paced, personalized, and interactive. - It is accessible 24 hours a day, 7 days a week, for any number of employees in any geographical location. - It ensures uniform and up to date content - the same information is delivered to all users and can be updated quickly to reflect industry developments. e-Learning doesn't replace instructor led training or 'hands-on' experience; rather it augments and enhances both. In an environment characterized by rapid changes in technology and regulations, e-learning is a critical part of any comprehensive training solution. Any e-learning solution stands or falls on the quality of its content. Content is king. We combine unsurpassed content with value-added services and an international presence. We deliver an innovative e-learning environment that combines the latest advances in learning theory with leading-edge Internet technology. Our lessons contain state-of-the-art graphics, animations and content with interactive components. Our powerful yet simple framework is designed specifically for regulated industries and our flexible lesson format integrates seamlessly into existing training programs. e-Learning for the Regulated Industries We understand the demands and expectations placed on today's QA and training teams. In Regulated Industries training is critical. Not only are you required to conduct and record training in your facility but poor training strategies can lead to: - manufacturing problems - product failure - negative publicity - product recalls - loss of income Whatever the scope of your regulatory training needs, we have a solution for you. Site-wide or enterprise-wide, we can help you keep pace with Regulatory requirements and Industry practices. e-Learning is a perfect fit for the Regulated Industries. Why? - Most corporations operate on an international, cross-boundary level. Our Courseware offers a cost-effective, uniform standard of training across all of your company's operations, regardless of geographical location. - Our courses are deliverable 24 hours a day, 7 days a week, enabling you to plan your training needs to suit your company's production shifts and working arrangements. - Our delivery system is compliant with FDA Regulation 21 CFR Part 11 which governs storage of electronic data, allowing you to organize, manage, record and store employee training records with confidence. Delivery Solutions We offer you the flexibility of Internet or local delivery for our Courseware. Choosing from one of our own proprietary LMSs (Skillpad PRO, NET or LITE), our Lessons can be delivered on your organization's Intranet/LAN or delivered to you from our secure hosted servers through your Internet connection. KEY FEATURES: Behind-the-firewall LMS - Launches and tracks training content and assessments - Built-in assessment engine - Unique Regulatory-Focused 'Sign-Off & Approval' System - Trainees/Trainers can 'sign-off' using an electronic signature - Full Audit Trail - Validation Protocol templates provided - Extensive Reports - Built-in Collaboration - messaging system can integrate with corporate email systems KEY FEATURES: Internet Hosted LMS - No additional hardware required, access from Internet browser - Dedicated or shared server options available - Launches and tracks training content and assessments - Content & application upgrades automatically installed Integration with Other LMS Applications We follow guidelines laid out by Standards Committees such as AICC and ADL's SCORM. If you already have an LMS installed, consider adding our media-rich interactive Lessons to get the most out of your Corporate LMS.