This course bundle provides comprehensive medical device regulatory requirements for all five countries currently utilizing MDSAP audits in their regulatory framework: Australia, Brazil, Canada, Japan and the United States. These five separate courses can also be purchased individually. Read More

According ​to ​the ​Dietary ​Supplement ​Health ​and ​Education ​Act ​(DSHEA), ​any ​company ​that ​sells ​a ​dietary ​supplement ​containing ​a ​new ​dietary ​ingredient ​must ​submit ​a ​New ​Dietary ​Ingredient ​Notification ​(NDIN) ​to ​the ​FDA. ​In ​this ​course ​we ​will ​provide ​guidance ​on ​how ​to ​determine ​when ​an ​NDIN ​is ​required, ​what ​kind ​of ​information ​you ​will ​need ​to ​include ​in ​an ​NDIN, ​and ​common ​pitfalls. ​The ​course ​is ​directed ​toward ​dietary ​supplement ​and ​food ​ingredient ​manufacturers ​and ​suppliers ​who ​are ​interested ​in ​understanding ​the ​basic ​requirements ​for ​NDINs ​so ​they ​can ​better ​communicate ​with ​regulators ​and ​specialists. Specific topics will include: • How to determine whether you need to submit an NDIN to the FDA • How to decide what kind of testing is required for an NDIN • How to establish safety under the conditions of intended use • How to compile the necessary documentation for a successful FCN • How to avoid common pitfalls associated with preparing an NDIN Instructor: Brad Lampe Please note a PDF of the recording will not be available. You will have access to the recoding for 15 days once you complete your registration. Certificate of participation are not issued for recorded courses​. Read More

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