IPEC-Americas 2021 webinar topics Survey

Incorporation of Pharmaceutical Excipients into a Quality-by-Design (QbD) Development Project
This webinar (free to IPEC members) is intended to focus on and in-depth review and discussion of the current scope/objectives/content of the QbD guide, including examples of an excipient used in support of a pharmaceutical QbD project. The webinar will cover excipient variability impact on excipient performance and cGMP requirements and should incorporate learnings from the EW Guide WS and should include examples of how excipient suppliers and users might support and/or utilized the concepts from the guide.

Revision of IPEC Excipient Qualification Guide and Checklist
This webinar (free to IPEC members) is intended to provide an overview of changes and strategy for the soon to be released revised IPEC Qualification of Excipients for Use in Pharmaceuticals Guide and Checklist, first developed an published in 2008. The primary objective of the guide (referenced globally) is to identify minimum information needed to support the marketing of materials for use as excipients as well as their use by pharmaceutical companies. A new "quick reference" checklist, has also been designed and included.

Update on nitrosamines
Nitrosamines and related compounds continue to be a hot topic among regulatory agencies in the U.S., Europe, Canada, Brazil and elsewhere. The presenters will continue to explore what the pharmaceutical industry (excipient manufacturer and excipient users) are doing to support regulations and enquiries from regulatory authorities.

Update on TiO2
This webinar is an update of a 2019 IPEC-Americas webinar that first introduced the topic and is intended to provide a current understanding for the potential impact of TiO2 activities on pharmaceutical products/ingredients. As expected, suspension for the use of TiO2 in pharmaceuticals and cosmetics is becoming more of a potential concerns and could result in drug product changes/potential shortages.

Microplastics Part 2 – Continued Issues and Impact on Pharmaceutical Products
This webinar is an extension to a 2019 IPEC-Americas webinar. As previously noted, the European Chemicals Agency (ECHA) is moving forward with proposed restrictions on the use of microplastics in products used in various market segments - including medicinal products. ECHA's broad definition of microplastics, may impact many excipients that may result in restrictions or increased labeling and reporting requirements. This webinar will provide excipient suppliers and users with an update of the current situation.

US Laws, regulations, and industry best practices for excipients, including filing an excipient DMF with the US FDA
This webinar, part of a library of regional specific webinars, would be a 2-part series intended to provide a road map for how the regulatory process in the US works relative to the use of excipients. Focused on requirements for: 1) excipient manufacturers/suppliers, 2) drug manufacturers and 3) US FDA drug application reviewers. Potential topics to include: 1)overview of responsible agencies and standards for drug regulation, 2) regulatory/testing requirements, 3) requirements/resources for filing a US Type IV DMF, 4) regulations for colorants/flavors, 5) emerging challenges.

Overview of excipient laws and regulations in Japan
This webinar, part of a library of regional specific webinars, would focus on current and emerging regulatory activities in Japan related to the use of excipients. Content to be developed in collaboration with IPEC company reps/IPEC Japan. Potential topics to include: 1)overview of responsible agencies and standards for drug regulation, 2) regulatory/testing requirements, 3) information needed for drug application approval 4) requirements/resources for filing a Japan DMF and Foreign Manufacturer Accreditation), 4) import requirements for excipients 5) regulations for colorants/flavors and 6) emerging challenges.

Overview of excipient laws and regulations in Europe
This webinar, part of a library of regional specific webinars, would focus on current and emerging regulatory activities in Europe related to the use of excipients. Content to be developed in collaboration with IPEC company reps/IPEC Europe. Potential topics to include: 1)overview of responsible agencies and standards for drug regulation, 2) regulatory/testing requirements for excipients, 3) CEPs 4) licensing/registration (local and imported), 5) regulations for colorants/flavors, 6) emerging challenges.

Overview of excipient regulations in Latin America
This webinar, part of a library of regional specific webinars, would focus on current and emerging regulatory activities in Latin America and could potentially be a joint webinar with partner associations in LATAM. Potential topics to include: 1)overview of responsible agencies and standards for drug regulation, 2) regulatory/testing requirements, 3) information needed for drug application approval 4) licensing/registration (local and imported), 5) regulations for colorants/flavors and 6) emerging challenges.

Overview of excipient laws and regulations in China
This webinar, part of a library of regional specific webinars, would focus on current and emerging regulatory activities in China related to the use of excipients. Content to be developed in collaboration with IPEC company reps/IPEC China. Potential topics to include: 1)overview of responsible agencies and standards for drug regulation, 2) regulatory/testing requirements for excipients, 3) excipient dossier filing 4) China’s joint review process, 5) regulations for colorants/flavors, 6) emerging challenges, and 7) ChP 2020.

Navigating the confusion for US dietary supplements and their ingredients
Dietary supplements in the US have separate regulations from pharmaceuticals and food. Likewise the ingredients used in supplements must meet specific FDA requirements. Should these be excipients or food additives? Find out more about these regulations, compendial requirements and other expectations for the non-dietary ingredients in supplements.

Real Complexity of Excipient Composition: how additives, processing aids, concomitant components and impurities are handled in today's regulatory environment
This webinar will cover excipient composition and how additives and processing aids are being handled in today’s regulatory environment and defining the term "impurity. Webinar would: 1) describe types of excipients, excipient composition profiles and USP/NF labeling requirements, 2) assert that drug products manufactured with excipients containing undeclared additive and process aids should not be considered adulterated/misbranded and 3) explore challenges of understanding concomitant components as part of the excipient composition profile and supported development of an informational USP General Chapter (i.e. >1000) for characterization of excipient composition.

Complexities and Confusion in Aligning Excipient Nomenclature in USP, SRS (UNII) and IID
This webinar would incorporate and summarize information on: 1) how/when are UNIIs generated, 2) how UNIIs are used, 3) where UNII "synonym" information comes from, 4) impact naming and/or use of UNIIs has on excipient suppliers, 5) impact naming and/or UNIIs has on generic sponsors, 6) issues with aligning USP, SRS and IID nomenclature for excipients and 7) some of the challenges in developing nomenclature for co-processed excipients.

TUPS Pt 2-Advanced training Technically Unavailable Particles in Excipients-Procedural Approaches
This updated webinar will discuss how low levels of visible particles can result from the excipient manufacturing, handling, or packaging processes, which do not look like the rest of the batch but pose no risk to formulation or patient safety. The appearance of these particles has caused users to reject batches of excipient upon visual inspection due to a lack of understanding of their nature. The IPEC TUPPs Guide was recently quoted by the ECA GMP Certification Programme (Feb 2020) as one of the best practice guides (globally) for a standard approach to controlling foreign particles in APIs and pharmaceutical excipients.

Significant Change
This webinar would be a repeat of an April 2015 webinar and would cover: 1) the "What" - A uniform approach to significant changes in manufacturing and distribution of excipients, 2) the "Whys" - Importance and benefits of a uniform approach to significant change and the impact of changes on excipient quality and performance, and 3) the "Hows" - Understanding and applying the requirements set forth in the 2014 IPEC Significant Change Guide, including when to use Risk Assessment to assess a change and examples of specific changes and their categorization as "Significant" or "Not Significant"

Data Integrity, Part 2: Practical examples and potential solutions
This webinar would review data integrity principles as they apply to excipient product quality and patient safety and would align with the Federation position paper. Key points included: 1) data integrity and application to excipient, 2) alignment of data integrity principles with excipient GMPs, 3) regulatory guidance not directly applicable to excipients, 4) finished drug product/API regulatory guidance potentially applicable to excipients, 5) application of data integrity principles where loss of data integrity would directly harm the patient or cause rejection of finished drug product and 6) development of a data integrity plan.

Excipient Stability – Use of Expiration/ Retest Dates and Accelerated Stability
This webinar would cover excipient stability and the need for any special stability information. The webinar would include: 1) why excipient stability data is necessary, 2) what stability testing should include, 3)definition for stability terms, 4) overview of IPEC Excipient Stability Program Guide, 5) conducting accelerated and climate zone stability studies, 6) overview of IPEC position paper on excipient stability, and 7) remaining shelf-life requirements.

Escalating Audit Requirements are Making Acceptance and Adoption of Third-Party Accredited Excipient GMP Audits Critical
This webinar (based on a 2018 PharmTech publication) would cover such things as: 1) current audit burden facing Pharma, 2) recognized consensus standards and auditing programs for excipient GMPs, 3) benefits of excipient GMP certification, 4) best practices for pharmaceutical companies utilizing GMP audit reports/certificates, 5) critical process steps to excipient GMP certification, and 7) pharmaceutical company considerations when using excipient GMP audit reports/certificates.

cGMP for internal auditors
The purpose of an internal audit is to assess the effectiveness of an organization’s quality management system (QMS) and their overall performance. In addition to confirming compliance with GMPs, an internal audit should demonstrate how the company's processes are implemented and maintained. This webinar would focus on expectations, requirements and best practices for internally auditing a company's QMS for excipient GMPs.

Gluten in drug products (source, limit, analysis, labeling, etc.)
This webinar would review IPEC-Americas opinion and comments related to an FDA 2018 Guidance titled "Gluten in Drug Products and Associated Labeling Recommendations" and would cover information related to gluten in drug products (including: source, limits, analysis, labelling, etc.). In addition, the webinar would review IPEC-Americas rebuttal to Shah publication

IPEC-Americas 2021 webinar topics

Question Title

* 1. Choose your top seven webinar topics