First-of-its-Kind ISPE Ask Me Anything Event Addresses Questions on ISPE Communities of Practice
ISPE members came together to ask questions about ISPE Communities of Practice (CoPs) in a live session hosted by Tim Postlethwaite, Director of Technical Communities with ISPE, and Anna Riley, Member Operations Manager with ISPE.
The Ask Me Anything event was the first of its kind and took place via a discussion thread on the ISPE Engage platform. Members asked questions about how to join, how and why to participate, plans for 2024, and more. Here are some highlights from the conversation.
Who started [CoPs] and why?
ISPE CoPs were established nearly 20 years ago to serve ISPE members and the industry at large by providing an organizational structure for ISPE subject matter experts to share knowledge relevant to specific topics and to generate content and to disseminate that content to the industry.
How does participation in a CoP benefit me?
The benefits are numerous. Examples include networking and engaging with other member SMEs, sharing and receiving community knowledge, opportunities to generate ISPE content, present at ISPE conferences, and comment on proposed regulatory items.
What communities are available to join?
All CoPs are open for members to join. You join by selecting the desired CoP in your ISPE profile. When logged in, select “My Account” and go to the “My Interests and Communities” tab and scroll to the CoP list at the bottom of that page.
Are new CoPs launching in 2024?
Two new CoPs are planned to launch in 2024, Sustainability and Artificial Intelligence.
What is expected of COP members when they sign up to be a part of the COP?
Joining a CoP provides a member with access to that CoPs ISPE Engage page. On that page, you can post questions or read other threads on the CoP topic.
How do I get more involved with my CoP?
- Join one or more CoPs through your ISPE profile (When logged in to your ISPE.org account, select My Account and go to the My Interests and Communities tab and scroll to the CoP list at the bottom of that page. Join by ticking the box next to the desired CoP(s).)
- Once joined, you will be provided with access to the ISPE Engage page for that CoP or CoPs here.
- Engage by posting thoughts, questions, and discussion topics on the ISPE Engage CoP specific discussion pages or in the ISPE Open Forum which all ISPE Members have access to.
- To volunteer for more involvement, send an email to communities@ispe.org.
What is a SIG and who can get involved?
Special Interest Groups are technical teams established by the GAMP CoP Steering Committee. All are listed here. They can be joined through your ISPE profile and meetings are open to ISPE members. If interested, please send an email to communities@ispe.org.
Can anyone participate as an SME on a discussion forum?
Anyone that joins a CoP through their ISPE profile can ask or respond to questions on that CoP's discussion forum.
[Do CoP threads] contain best practice articles, links, or other types of content? Or is each [one] a thread of conversations only? Thanks.
Hi! On the ISPE Engage Open Forum, where we are now, each thread is a conversation initiated by a member. When you join a CoP via your ISPE profile, you will have access to that CoP's exclusive Engage site. Some CoPs do upload content to those sites, but not all. CoP members contribute to ISPE content (ISPE guidance documents, PE Magazine articles, iSpeak Blog posts, etc.). Those can be found on the ISPE website, although they are not always linked back to the CoPs that originated them.
Good [day.] I would like to obtain more knowledge about the validation of computerized systems, and everything related to this topic, thank you.
Good question! See the GAMP Guides listed here. A good place to start is Appendix M1 of ISPE GAMP© 5 Second Edition.
Hi, I am a graduate student in Biotechnology and [I’d kindly] like to know if the ISPE communities of practices offer a mentor-mentee pairing? Thanks in advance.
Joining a CoP provides a member with access to that CoP’s ISPE Engage page. On that page, you can post questions or read other threads on the CoP topic. There, you can also access SMEs in particular fields for guidance and information on professions within the pharmaceutical industry. ISPE also offers the Mentor ISPE program powered and led by Women in Pharma® several times a year, you can find out more information here.
How will ISPE promote generative technology in [the pharmaceutical] Industry?
ISPE is working to establish an Artificial Intelligence/Machine Learning Community of Practice. This will launch later in 2024. Please watch for more information.
Will there be a COP Day event like last year?
A CoP Day for 2024 has been proposed and is being considered. Please stay tuned. Your interest is appreciated. I will be participating in an ISPE Emerging Leader Day virtual event on 8 March 2024, representing the CoPs. Announcements for that event will go out soon .
What are technical topics you would like to see featured on a future ISPE Engage AMA Event? Let us know on the ISPE Open Forum or by emailing ask@ispe.org.
