Propose Your Topic to ISPE You are invited….

advertisement
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):
ƒ 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)
Download