Propose Your Topic to ISPE You are invited…. ISPE is very interested in your ideas for education programming publications, and other knowledge resources, and invites Subject Matter Experts (SMEs) to fully participate in their development. Please use this form to submit your ideas. PLEASE NOTE: ISPE is now using this one single submission form for all topics that may be considered in its Online Learning (webinars, online courses, etc.), Continuing Education, Training, Technical Documents, and publications, including Pharmaceutical Engineering magazine, Knowledge Briefs, and E-letters. www.ISPE.org/CallForProposals Timing • Proposals are accepted year-round, but there is an annual push that especially applies to conferences; this date is about 10 days after each year’s Annual Meeting for the following year’s Annual Meeting and conferences two years hence. Directions • • • • • • • Use this form if you are an individual or a group who wishes to propose a single or group of topics for consideration. This form is for individual as well as group submissions Prepare this submission as if it were going to be used to develop a description for marketing Leave blank those sections that do not apply Submit in Word or PDF to: o Julianne Rill or Marianne Bock for Continuing Education o Ali Montes for Training o Rae Hayward for Webinars o Gloria Hall for Publications Proposals will be acknowledged when received and will be catalogued for periodic review. They will be catalogued under the last name of the submitter and the date submitted. Please keep a copy for your records. Name of COP, Chapter, Affiliate, or Group submitting (if applicable): Name of One Contact Person: The Most Important Key Word or Phrase (e.g. GAMP): Member Number (if known): Company: Job Title: Address: City: State/Province: Postal Code: Phone: Fax: Email Address: 1. Target Geographic Area: (Rank order; you can have more than one labeled “1.”) Asia Pacific Europe North America / South America Other: Country: 2. I (We) would prefer this to be considered for: (check all that apply) Conference Annual Meeting Session Conference Seminar Online Learning Podcast Webinar Publication Pharmaceutical Engineering New Technical Document Knowledge Brief E-letter Training Online Course Classroom Course Other knowledge resources (e.g., Web site content). 3. This session is sponsored by the Community(ies) of Practice. (If applicable) 4. Title: 5. Description [300 words maximum] 6. Explain why this is a good idea, is a timely idea, should be considered because… or anything else you would like the reviewers to understand why this is important and why it is important now. 7. Has this content been published or presented before, through another organization? If so, please provide the details and why it is still important for ISPE consider it. 8. Content Developers, Authors, or Presenters Identified (Note those that have committed to the project by placing a [C] after their name.) • SAMPLE: Name, Job Title, Company, COUNTRY • • • 9. Identify Communities of Practice (COPs): Check all that will be your target audience. API Biotech C&Q Containment Critical Utilities Disposables Eng Standards Benchmarking GAMP Good Control Lab Practices HVAC Investigational Products Operations Management OSD Packaging PAT Product Process Dev. Project Management Sterile Products Processing Sustainable Facilities 10. Are there any other organizations that we should approach to help us market this opportunity? To whom we should market (e.g. other professional societies)? 11. List any existing, related ISPE technical docs and/or PE, JPI articles, or any other ISPE resources that connect with or cross over what you are proposing. 12. List Google Search Words relevant to this proposal: The remaining items refer specifically to conferences, online learning/webinars and training. 13. Participant Objectives; Complete the following sentence with three to five phrases starting with verbs such as understand, analyze, describe, apply) At the conclusion of this education session, participants will be able to: • • • 14. Who Should Attend (e.g., job titles): 15. Education content can best be described as: Fundamental Intermediate Advanced 17. Identify the CPIP Elements this will address by checking those elements that are relevant. 1 - Product Development Formulation, clinical phases, and manufacture Technology transfer Production scale-up and optimization 2 - Facilities and equipment Design and construction/installation Commissioning and qualification as a risk management strategy Operation and maintenance Controls and automation 3 - Information systems 4 - Supply chain management Materials management Operational economics Warehouse and distribution management 5 - Production systems Production unit operations - drug (small molecule) and biologics Production management Production Control 6 - Regulatory compliance (includes drugs, environmental, health and safety) Government regulations Standards, practices, and guides 7 - Quality systems Risk management and Quality Management System (QMS) Systems validation (changed from Validated Controls)