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Manufacturing</a></div><h1 class="product_title entry-title"><H2>Introduction to CMC Analytics for Biologics, Cell & Gene and Biosimilars</H2> <H4>Coming Soon | 2-Day Live Online Course</H4></h1><div class="separator small left qode-sp-separator"></div><p class="price"></p> <div class="woocommerce-product-details__short-description"> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><div class="vc_empty_space" style="height: 10px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div></p> <p><strong>Examine Phase-Appropriate Regulatory, Technical and Quality Elements for Characterisation, Comparability, and Control Strategies</strong></p> </div> <form class="variations_form cart" action="https://educolifesciences.com/product/introduction-to-cmc-analytics-for-biologics-cell-gene-and-biosimilars-training-course/" method="post" enctype='multipart/form-data' data-product_id="15550" data-product_variations="[]"> <p class="stock 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</form> </div> </div> </div></div></div></div></div></div></div><div data-q_id="#OurStory" class="vc_row wpb_row section vc_row-fluid grid_section" style=' padding-top:25px; padding-bottom:25px; text-align:left;'><div class=" section_inner clearfix"><div class='section_inner_margin clearfix'><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner"><div class="wpb_wrapper"></div></div></div></div></div></div><div data-q_id="#OurStory" class="vc_row wpb_row section vc_row-fluid grid_section" style=' padding-top:25px; padding-bottom:25px; text-align:left;'><div class=" section_inner clearfix"><div class='section_inner_margin clearfix'><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner"><div class="wpb_wrapper"><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p style="text-align: center;"><em><strong>Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.</strong></em></p> </div> </div> <div class="vc_empty_space"></div> </div> </div><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div><div class="qode-advanced-tabs qode-advanced-tabs qode-advanced-horizontal-tab clearfix qode-advanced-tab-without-icon qode-advanced-tabs-column-6 clearfix"> <ul class="qode-advanced-tabs-nav"> <li> <h2> <a href="#tab-course-overview"> <span class="qode-advanced-tab-text-after-icon"> Course Overview </span> </a> </h2> </li> <li> <h2> <a href="#tab-key-learning-objectives"> <span class="qode-advanced-tab-text-after-icon"> Key Learning Objectives </span> </a> </h2> </li> <li> <h2> <a href="#tab-what-is-included"> <span class="qode-advanced-tab-text-after-icon"> What is Included? </span> </a> </h2> </li> <li> <h2> <a href="#tab-course-dates"> <span class="qode-advanced-tab-text-after-icon"> Course Dates </span> </a> </h2> </li> <li> <h2> <a href="#tab-looking-to-train-your-team"> <span class="qode-advanced-tab-text-after-icon"> Looking to Train Your Team? </span> </a> </h2> </li> <li> <h2> <a href="#tab-other-course-info"> <span class="qode-advanced-tab-text-after-icon"> Other Course Info </span> </a> </h2> </li> </ul> <div class="qode-advanced-tab-container" id="tab-course-overview-258" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2>Course Overview</h2> <p> </p> <p>Biological therapeutics and vaccine products require an array of analytical methods to characterise their biomolecular structure and biological functions. The CMC elements needed to support product safety and efficacy are defined in a diverse array of regional and global regulatory guidances. The molecular complexity of each biological product dictates the analytical technologies necessary for its characterisation, comparability, and control strategies. But all biological product modalities require similar types of CMC analytical studies and key analytical data sets during development.</p> <p> </p> <p>This introduction to CMC analytics for biologics, cell & gene and biosimilars course will provide you with a comprehensive overview of the phase-appropriate analytical expectations for biological products of any type (novel or biosimilar protein therapeutics, well-characterised or classic vaccines, advanced cell or gene therapies). Once completed, you will understand which analytical studies are needed, why they are important, and where to find technical guidance for your specific product modality. You will learn the most common mistakes made in method lifecycle elements, reference standard management, stability programs and comparability studies, and how to avoid them, especially under highly accelerated CMC timelines.</p> <p> </p> <p>With the Educo <strong><a href="https://educolifesciences.com/post-learning-implementation-plan/" target="_blank" rel="noopener">Post Learning Implementation Plan (PLIP)</a></strong> you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. <strong><a href="https://educolifesciences.com/live-online-training/" target="_blank" rel="noopener">Learn more about how we deliver live online training</a>.</strong></p> </div> </div></div><div class="qode-advanced-tab-container" id="tab-key-learning-objectives-736" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2>Key Learning Objectives</h2> <p> </p> <ul> <li>Learn which CMC analytical data packages are required for all biotech and cell & gene products, and why.</li> <li>Discover where the ‘rules’ for biological products are written in regulatory and compliance documents.</li> <li>Review critical ICH Guidelines such as ICH Q5A, ICH Q5B, ICH Q5C, ICH Q5D, ICH Q5E, ICH Q6B.</li> <li>Examine phase-appropriate considerations for qualification/validation/verification of methods.</li> <li>How should product reference standards be established, monitored, and bridged over time?</li> <li>Understand the analytical considerations for biological/cell & gene product release and stability specifications.</li> <li>Identify the most challenging elements of analytical comparability studies.</li> <li>How to find analytical information on traditional, biosimilar, or cell & gene products?</li> <li>Review the specific challenges and opportunities when using, or being, a CRO analytical lab.</li> </ul> </div> </div></div><div class="qode-advanced-tab-container" id="tab-what-is-included-870" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2>What is Included in a Live Online Course?</h2> <p> </p> <ul> <li>Direct access to an expert trainer.</li> <li>Interactive and engaging sessions with exercises and discussions.</li> <li>Bitesize learning.</li> <li>Access to the Educo Life Sciences Training Portal.</li> <li>Unlimited access to the recordings for 4 to 5 weeks after the last session.</li> <li>A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.</li> <li>A validated certificate of attendance is available for you to download.</li> </ul> </div> </div></div><div class="qode-advanced-tab-container" id="tab-course-dates-441" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2>Course Dates</h2> <p> </p> <p>Find out when this course is running so you can plan your training. Scroll down to view the full agenda.</p> </div> </div><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4>Dates TBC</h4> <p><strong>1 Week Live Online Training</strong><br /> Register at the top of the page.</p> </div> </div><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div></div><div class="qode-advanced-tab-container" id="tab-looking-to-train-your-team-941" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2><strong>Group Discount</strong></h2> <p> </p> <p>If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.</p> <p> </p> <p style="text-align: left;">For a quote, complete our contact form by following the link. <a href="https://educolifesciences.com/contact/" target="_blank" rel="noopener"><strong>Get in touch.</strong></a></p> </div> </div><div class="vc_empty_space" style="height: 50px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2><strong>Customised Team Training</strong></h2> <p> </p> <p>We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.</p> <p> </p> <p style="text-align: left;">For more information, complete our contact form by following the link. <a href="https://educolifesciences.com/contact/" target="_blank" rel="noopener"><strong>Get in touch.</strong></a></p> </div> </div></div><div class="qode-advanced-tab-container" id="tab-other-course-info-499" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2><strong>Free Online</strong><strong> Module</strong></h2> <p> </p> <ul> <li>Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.</li> <li>To register for module 1, please submit your details in the form located in the agenda.</li> <li>Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.</li> </ul> <p> </p> <h2><strong>Full Course Information and Pricing</strong></h2> <p> </p> <ul> <li>To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.</li> <li>There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.</li> <li>The full training course is delivered either online or in a classroom. Please check which course format you have booked.</li> <li>For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.</li> <li>For live online courses – The dates and times of modules/sessions are subject to change.</li> <li>For live online courses – The module/session durations are approximate.</li> </ul> <p> </p> <p><a href="https://educolifesciences.com/faqs/" target="_blank" rel="noopener">Frequently Asked Questions (FAQs)</a></p> </div> </div></div></div></div></div></div></div></div></div><div data-q_id="#about" class="vc_row wpb_row section vc_row-fluid grid_section" style=' padding-top:50px; padding-bottom:25px; text-align:left;'><div class=" section_inner clearfix"><div class='section_inner_margin clearfix'><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p style="text-align: center;"><em><strong>Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)</strong></em></p> </div> </div><div class="vc_empty_space" style="height: 10px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div><div class="vc_empty_space" style="height: 10px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div><div class="qode-advanced-tabs qode-advanced-tabs qode-advanced-horizontal-tab clearfix qode-advanced-tab-without-icon qode-advanced-tabs-column-3 clearfix"> <ul class="qode-advanced-tabs-nav"> <li> <h2> <a href="#tab-agenda"> <span class="qode-advanced-tab-text-after-icon"> Agenda </span> </a> </h2> </li> <li> <h2> <a href="#tab-trainer"> <span class="qode-advanced-tab-text-after-icon"> Trainer </span> </a> </h2> </li> <li> <h2> <a href="#tab-who-should-attend"> <span class="qode-advanced-tab-text-after-icon"> Who Should Attend? </span> </a> </h2> </li> </ul> <div class="qode-advanced-tab-container" id="tab-agenda-815" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> </div> </div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5>Post Learning Implementation Plan (PLIP)</h5> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><span style="font-weight: bold;">Pre-course</span></p> <ul> <li>Access to the Educo Training Portal</li> <li>Submit your needs analysis and objectives for training by completing a simple online form</li> </ul> <p><strong>Action Plan</strong></p> <ul> <li>At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge</li> </ul> <p><strong>Reinforcement Session </strong></p> <ul> <li>Delivered 3 to 4 weeks after the training</li> <li>It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover subsequent questions and challenges</li> </ul> </div> </div></div></div></div></div></div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5 id="module-1-form">Introductory Module 1</h5> <h4>FREE to Attend | Live & Recorded</h4> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Introduction to CMC analytics for biologic, cell & gene, vaccine and biosimilar products</strong></p> <ul> <li>Introduction to CMC analytics</li> <li>Overview of the challenges during development and manufacturing</li> <li>Highlight important guidelines you should be aware of</li> </ul> </div> </div><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div></div></div></div></div></div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5>Day 1</h5> <p><strong>DD MMM 2023 | Session 1 | 120 mins | 13:00 PM UK</strong></p> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Current CMC regulatory requirements and hot-button issues for biological and cell & gene products<br /> </strong></p> <ul> <li>Why do biological product CMC requirements differ from those of chemical products?</li> <li>Why are there different safety concerns about biological product and process related impurities?</li> <li>Which specific worldwide regulations detail CMC study requirements for biological and cell & gene products?</li> <li>What are the relevant ICH Guidelines such as ICH Q5A, ICH Q5B, ICH Q5C, ICH Q5D, ICH Q5E, ICH Q6B.</li> <li>What CMC analytical data packages are required for regulatory approval of all biological and cell & gene products?</li> <li>When should these CMC studies be done during the product development lifecycle?</li> <li>How are these CMC studies impacted by accelerated clinical programs?</li> <li>Which of these CMC data are generated in GMP vs R&D labs?</li> <li>What is the risk of CMC data generated by non-GMP AD/PD R&D labs?</li> <li>What are commonly implemented quality practices for CMC AD/PD R&D labs?<strong><br /> </strong></li> </ul> </div> </div></div></div></div></div></div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>DD MMM 2023 | Session 2 | 120 mins | 3:15 PM UK</strong></p> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Phase-appropriate analytical method lifecycle expectations for biological and cell & gene products</strong></p> <ul> <li>What is the difference between method qualification and method validation?</li> <li>When is a method qualification acceptable, and when is a method validation necessary?</li> <li>What is required for the verification of compendial methods?</li> <li>What are the most important elements a correct method qualification/ verification/validation study?</li> <li>Which method validation parameters are usually designed incorrectly for biological and cell & gene products?</li> <li>What are the requirements when making changes in analytical methods at any phase?</li> <li>What are the key elements of method tech transfer studies (changing from lab A to lab B)?</li> <li>What are the key elements of method bridging studies (changing from method A to method B)?</li> <li>How are changes staged for methods being used in stability protocols?</li> <li>What are key considerations when using contract testing laboratories for analytical methods?</li> </ul> </div> </div></div></div></div></div></div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5>Day 2</h5> <p><strong>DD MMM 2023 | Session 1 | 120 mins | 13:00 PM UK</strong></p> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Specifications, reference standards, and critical assay reagents</strong></p> <ul> <li>What are the key characteristics of any biological and cell & gene products that require control and consistency?</li> <li>Where can you find the analytical methods currently being used for various biological and cell & gene products?</li> <li>What four critical elements are needed for the establishment of meaningful, reliable specifications?</li> <li>What are some of the types and uses of biological reference standards and materials?</li> <li>What is the tiered approach to biological product reference standards?</li> <li>What are the critical elements of bridging biotech physiochemical vs potency reference standards?</li> <li>What are the current expectations for characterisation, comparability, and control of HCPs?</li> <li>Which process impurity reference standards are required for recombinantly-expressed products?</li> <li>How should critical reagents/materials be managed to better assure consistent method performance?</li> </ul> </div> </div><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div></div></div></div></div></div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>DD MMM 2023 | Session 2 | 120 mins | 13:00 PM UK</strong></p> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Phase-appropriate stability and comparability requirements for biological and cell & gene products</strong></p> <ul> <li>What are the phase-specific requirements for biological and cell & gene product stability studies?</li> <li>How is the stability-indicating profile of a biotech product experimentally established?</li> <li>What data are required in the validation of stability-indicating methods?</li> <li>Why are stability data the main indicator of performance variability in validated methods?</li> <li>What are the critical logistical elements of a stability protocol at any phase of development?</li> <li>What are target, accelerated, stressed and forced conditions for biological and cell & gene products?</li> <li>Why can’t biological and cell & gene product shelf life be extrapolated from accelerated stability data?</li> <li>What is the core paradigm to follow when making changes to biological processes?</li> <li>What is the tiered approach to comparability studies for biological products?</li> <li>What are the important procedural elements of an analytical comparability study?</li> <li>How do comparability studies change relative to the phase of product development?</li> </ul> </div> </div></div></div></div></div></div></div><div class="qode-advanced-tab-container" id="tab-trainer-173" data-icon-pack="" data-icon-html=""><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_single_image wpb_content_element vc_align_left"> <div class="wpb_wrapper"> <div class="vc_single_image-wrapper vc_box_border_grey"><noscript><img decoding="async" width="150" height="150" src="https://educolifesciences.com/wp-content/uploads/2023/02/Nadine-Pic-Small-150x150.png" class="vc_single_image-img attachment-thumbnail" alt="" title="Nadine Ritter" srcset="https://educolifesciences.com/wp-content/uploads/2023/02/Nadine-Pic-Small.png 150w, https://educolifesciences.com/wp-content/uploads/2023/02/Nadine-Pic-Small-100x100.png 100w" sizes="(max-width: 150px) 100vw, 150px" /></noscript><img decoding="async" width="150" height="150" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%20150%20150%22%3E%3C/svg%3E' data-src="https://educolifesciences.com/wp-content/uploads/2023/02/Nadine-Pic-Small-150x150.png" class="lazyload vc_single_image-img attachment-thumbnail" alt="" title="Nadine Ritter" data-srcset="https://educolifesciences.com/wp-content/uploads/2023/02/Nadine-Pic-Small.png 150w, https://educolifesciences.com/wp-content/uploads/2023/02/Nadine-Pic-Small-100x100.png 100w" data-sizes="(max-width: 150px) 100vw, 150px" /></div> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Nadine Ritter – CMC, Analytical Expert – Biologics & Advanced Therapies</strong></p> <p> </p> <p>Nadine M. Ritter, Ph.D., obtained her master’s and doctoral degrees in cell and molecular biology at Rice University (Houston, TX) on evolutionary mechanisms for subcellular translocation of mitochondrial proteins. She was engaged in basic academic research in the field of extracellular matrix proteins and the process of bone mineralization at the University of Texas Health Science Center in Houston for over 10 years.</p> <p> </p> <p>Dr. Ritter entered the biopharma industry as a protein chemist in analytical R&D at Abbott Laboratories (Abbott Park, IL). There, she performed development, validation, transfer, and troubleshooting of test methods for the analytical QC lab, generated protein characterization data for in vitro diagnostic product submissions, responded to FDA comments, contributed to compliance remediation efforts for QC inspection observations, and lead the ISO9000 certification of an R&D analytical lab.</p> <p> </p> <p>Dr. Ritter then became the Director of the Analytical Services Division of BioReliance (Rockville, MD), a major contract testing organization. There, she led a team of CMC scientists in the design and conduct of method qualification, validation, and transfer, product characterization and comparability studies, and QC release and stability testing. Projects included synthetic peptides and oligonucleotides, natural and recombinant proteins, monoclonal and polyclonal antibodies, and viral particles. She managed quality and compliance activities for the R&D, GLP and GMP activities conducted in her lab, and implemented Part 11 computer system requirements.</p> <p> </p> <p>In 1999, she created the first public training class specifically focused on biological product stability programs, which later grew into an award-winning CMC analytical training course. She conducts in-depth training workshops on all aspects of CMC analytics for biologically-derived products, updating class materials and reference documents each month.</p> <p> </p> <p>Since 2002, Dr. Ritter has been an international consultant, trainer, speaker and writer for biotech and biosimilar products. She first worked independently as NMR Biotech Services (Germantown, MD), then in 2004 joined Biologics Consulting Group, Inc. (Alexandria, VA).</p> <p> </p> <p>In 2014, she decided to return to independent consulting, forming Global Biotech Experts, LLC. Through Global Biotech Experts, she can bring in affiliate support from elite consulting colleagues with extensive experience in process development and validation, manufacturing facility PAI and GMP inspections, and technical writing for R&D and GMP applications.</p> <p>Throughout her career, Dr. Ritter has contributed to the success of over 120 international IND/IMPD and BLA/MAA filings and Post-Approval Change Protocols. She has engaged in numerous PAI readiness audits and due diligence inspections and has remediated analytical, regulatory and laboratory compliance problems around the world. She is on the CMC scientific advisory boards of several international biopharmaceutical companies.</p> </div> </div></div></div></div></div></div></div><div class="qode-advanced-tab-container" id="tab-who-should-attend-758" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p>This course provides a comprehensive overview of CGT. It is aimed at technical professionals who are either new to the industry or thinking about a career move into CGT. If you are a someone with experience in small molecules or biologics this course is will suit you.</p> <p> </p> <p><strong>These include:</strong></p> <ul> <li>Regulatory Affairs Professionals</li> <li>Production Personnel/Technicians</li> <li>Quality Professionals</li> <li>Clinical Professionals</li> <li>Process Development</li> <li>Personnel</li> <li>Scientists involved in Development</li> </ul> </div> </div></div></div></div></div></div></div></div></div> </div> </div> </div> </div> <div class="product_meta"> <span class="posted_in">Categories: <a href="https://educolifesciences.com/product-category/analytical-biotech-courses/" rel="tag">Analytical</a>, <a href="https://educolifesciences.com/product-category/biomanufacturing-courses/" rel="tag">Biomanufacturing</a>, <a href="https://educolifesciences.com/product-category/biotech-courses/" rel="tag">Biotech Courses</a>, <a href="https://educolifesciences.com/product-category/cell-and-gene-all-courses/" rel="tag">CGT Courses</a>, <a href="https://educolifesciences.com/product-category/cgt-manufacturing/" rel="tag">CGT Manufacturing</a></span> </div> <div class="related products"> <h4 class="qode-related-upsells-title">Related products</h4> <ul class="products"> <li class="product type-product post-16823 status-publish first instock product_cat-cell-and-gene-all-courses product_cat-cgt-manufacturing has-post-thumbnail taxable shipping-taxable product-type-variable"> <div class="top-product-section"> <a itemprop="url" href="https://educolifesciences.com/product/gmp-for-atmps-cell-and-gene-therapies-training-course/" class="product-category"> <span class="image-wrapper"> <noscript><img width="300" height="300" src="https://educolifesciences.com/wp-content/uploads/2023/03/3-300x300.jpg" class="attachment-woocommerce_thumbnail size-woocommerce_thumbnail" alt="" decoding="async" srcset="https://educolifesciences.com/wp-content/uploads/2023/03/3-300x300.jpg 300w, https://educolifesciences.com/wp-content/uploads/2023/03/3-150x150.jpg 150w, https://educolifesciences.com/wp-content/uploads/2023/03/3-570x570.jpg 570w, https://educolifesciences.com/wp-content/uploads/2023/03/3-500x500.jpg 500w, https://educolifesciences.com/wp-content/uploads/2023/03/3-1000x1000.jpg 1000w, https://educolifesciences.com/wp-content/uploads/2023/03/3-100x100.jpg 100w" sizes="(max-width: 300px) 100vw, 300px" /></noscript><img width="300" height="300" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%20300%20300%22%3E%3C/svg%3E' data-src="https://educolifesciences.com/wp-content/uploads/2023/03/3-300x300.jpg" class="lazyload attachment-woocommerce_thumbnail size-woocommerce_thumbnail" alt="" decoding="async" data-srcset="https://educolifesciences.com/wp-content/uploads/2023/03/3-300x300.jpg 300w, https://educolifesciences.com/wp-content/uploads/2023/03/3-150x150.jpg 150w, https://educolifesciences.com/wp-content/uploads/2023/03/3-570x570.jpg 570w, https://educolifesciences.com/wp-content/uploads/2023/03/3-500x500.jpg 500w, https://educolifesciences.com/wp-content/uploads/2023/03/3-1000x1000.jpg 1000w, https://educolifesciences.com/wp-content/uploads/2023/03/3-100x100.jpg 100w" data-sizes="(max-width: 300px) 100vw, 300px" /> </span> </a> <span class="add-to-cart-button-outer"><span class="add-to-cart-button-inner"><a href="https://educolifesciences.com/product/gmp-for-atmps-cell-and-gene-therapies-training-course/" aria-describedby="woocommerce_loop_add_to_cart_link_describedby_16823" data-quantity="1" class="button product_type_variable qbutton add-to-cart-button" data-product_id="16823" data-product_sku="" aria-label="Select options for “GMP for ATMPs (Cell and Gene Therapies)”" rel="nofollow">Read more</a></span></span> <span id="woocommerce_loop_add_to_cart_link_describedby_16823" class="screen-reader-text"> </span> </div> <a itemprop="url" href="https://educolifesciences.com/product/gmp-for-atmps-cell-and-gene-therapies-training-course/" class="product-category product-info"> <h6 itemprop="name"><H2>GMP for ATMPs (Cell and Gene Therapies)</H2> <H4>Register Your Interest</H4></h6> </a> <input type="hidden" class="wpmProductId" data-id="16823"> <script type="rocketlazyloadscript"> (window.wpmDataLayer = window.wpmDataLayer || {}).products = window.wpmDataLayer.products || {}; 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