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Dietary Supplement. Join us for a comprehensive virtual training, designed to build consumer and retailer trust in verified label claims by earning the sought-after “butterfly” logo for your products and ingredients. Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, participants in this course will: Learn how to help products stand out in the category with this collaborative 2-hour workshop for Non-GMO Project Verification, focusing on: Defining risk levels Classifying ingredients Identifying specific requirements for common dietary supplement ingredients Facility level compliance requirements Work through common sourcing and ingredient challenges with hands on exercises and case studies Make sense of complex regulations so they can be applied to your organization’s formulations and ingredients Become an in-house expert at Non-GMO Project definitions, standards and requirements Instructor: Marci Burton Note: A PDF of the presentation will not be distributed for this recording. You'll have access to the recording for 15 days once you complete your registration. Certificate of participation are not issued for recorded courses​. Read More

This self-paced digital learning course provides comprehensive instruction on Pharmaceutical Microbiology in pharmaceutical manufacturing.   The program is presented in three modules: - approximate course completion time = *5 hours. Once you finish the first module, you will automatically begin the next module within this course.   Module 1 - Introductory Topics – approximately 1 hour At the end of this module, you will: Explain Microbiological problems in the context of pharmaceutical manufacturing, including how to identify problems Learn the meaning of Microorganisms in their significance Understand HOW microorganisms grow and WHY it matters   ​Module 2 - Intermediate Topics – approximately 2.5 hours      At the end of this module, you will be able to: Review how microorganisms are counted and explain the rapid microbiological methods Outline the Identification of Microorganisms and explain pharmaceutical water systems Review Pyrogens and pyrogen testing Understand microbiological evaluations of raw materials Understand microbiological contamination and spoilage Learn the principles of preservation in the pharmaceutical context Understand Antibiotics and how to assess antimicrobial activity Outline and understand the importance of good disinfection practices   Module 3 - Advanced Topics – approximately 1.5 hours      At the end of this module, you will be able to: Review sterilization principles and methods Explain bio validation of sterilization Describe sterility testing in the pharmaceutical environment Discover Microbiological validation of cleanrooms Review Microbiological Environmental monitoring methods Learn how to perform a microbiological risk assessment *The course is self-paced so completion times are approximate, based on the amount of content in each section. Read More

Post-market surveillance for manufacturers is covered in Articles 83-86. Articles 87-89 cover post-market vigilance requirements. This course reviews the requirements set forth in these articles in detail, with expert advice provided throughout the course. Read More

This self-paced learning course provides comprehensive instruction on the Process Validation and Equipment Qualification in pharmaceutical manufacturing. The program is presented in three modules: - approximate course completion time = *4.5 hours. Once you finish the first module, you will automatically begin the next module within this course. Completing the three modules will provide learners with a holistic view of validation encompassing pre-validation studies, process development, and process evaluation, emphasizing modern approaches that apply principles of QbD, PAT, and ongoing quality risk management (QRM).   Module 1 - Introductory Topics – approximately 1 hour At the end of this module, you will be able to: Explain the differences between active pharmaceutical ingredients, a bulk drug substance, and drug product Explain the r purpose of equipment qualification and process validation Describe how performance supports product quality by reducing variability      Module 2 - Intermediate Topics – approximately 1.5 hours At the end of this module, you will: Understand WHY, WHAT, and HOW to perform validation Learn the stages of process validation Understand the importance of change control in the context of pharmaceutical quality systems Recognize the important of building in  system safeguards – engineered or procedural   Module 3 - Advanced Topics – approximately 2 hours At the end of this module, you will be able to: Discuss Modern Process Validation and Guidance (FDA and ICH) Understand the importance of pre-validation studies to develop process knowledge Outline the importance of Quality Risk Management and how it applies to process validation (ICH Q09) Identify the importance of validation design and how to reduce variability   Outline a framework for reducing potential product quality and patient risks during commercial manufacturing and throughout the product lifecycle   *The course is self-paced so completion times are approximate, based on the amount of content in each section. Read More

This self-paced learning course provides comprehensive instruction on Sterile Manufacturing Practices in pharmaceutical manufacturing.   This course utilizes real-world scenarios, embedded video and audio content to instruct on the practical application of these requirements. Engaging knowledge checks are provided throughout each module, and the course concludes with a final competency assessment. The program is presented in three modules: - approximate course completion time = *4.5 hours. Once you finish the first module, you will automatically be able to begin the next module.   Module 1 - Introductory Topics – approximately 1.5 hour Provides key information relevant to microorganisms and sources of contamination, particularly in manufacturing areas.  At the end of this module, you will be able to: Explain the basics of microbiology Recognize what constitutes a sterile versus non-sterile product Define Aseptic environment Identify how specific organisms can cause contamination Recognize how Mother Nature is a potential contamination source Identify other potential sources in a manufacturing area   Module 2 - Intermediate Topics – approximately 2 hours Provides common terminology used in sterile manufacturing procedures such as: Clean Room, Unidirectional air, First air, Restricted access barriers (RABS) versus isolators, autoclave cycle, and isolators.  At the end of this module, you will be able to explain: HVAC Requirements Clean Room requirements and clean room preparation Personnel and material flow Primary packing components Sterilization with both heat and radiation Depyrogneation Steam in place (SIP) Terminal Sterilization Sterile Filtration   Module 3 - Advanced Topics – approximately 2 hours Provides information related to the practical application of Sterile Manufacturing Practices.  At the end of this program, you will be able to: Describe routes of administration and associated patients Successfully complete the gowning process Explain the interrelation between materials, people, equipment and environment for aseptic processing Be aware of the critical controls in place Identify specialized filling technologies Providing an overview of lyophilization Explain container-closure integrity (CCI) Perform visual inspection Explain clean room monitoring *Completion times included are approximate and based on the amount of content included in each section. Content is self-paced, driven by the learner. Read More

In this 1-hour course, we will discuss the latest trends in FDA observations during their inspections of dietary supplement manufacturers. Discuss the Top 10 items that manufacturers are cited for, to help you in mitigating your risk and identifying non-conformances ahead of time. At the conclusion of this training participants will have an understanding of: • How to use the Code of Federal Regulations, Pharmacopoeias, and Guidance Documents as source information. • Who is the FDA and what power do they have? • How the FDA communicates with the company and how you should communicate with the FDA. • The top 10 items that dietary supplements manufacturers are cited for; and MOST IMPORTANTLY— The steps you can take to avoid each one of them! Instructor: Nicole Leitz Note: A PDF of the presentation will not be distributed for this recording. You'll have access to the recording for 15 days once you complete your registration.  Certificate of participation are not issued for recorded courses​. Read More

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