Hello, Our monthly meeting is this Thursday, 12PM PT.  We hope you can join us!

Agenda:

1. First time attendees/new member introductions

2. Standing:  Items of interest from other Communities to AAPS 

• ICH Guidance Updates: ICH M4Q,  ICHQ1 -  Kaly/Lori/All
• KENX Lab University  - Jun 4-6 (East Coast - Philadelphia): Lab management, Stability, Analytical Quality track  

3. Member Engagement: 

• Highlights & Reflections: Q1 Joint Quarterly Stability-Stats Meeting  
• Significant interaction/discussion in the community regarding Stability/LIMS systems, shelf-life projections, etc  - Kudos to the community!!

• Publications: Open access:
  • Lean Stability Case Studies—Leveraging Science- and Risk-Based Approaches to Enable Meaningful Phase Specific Pharmaceutical  
• 2 Articles: J. Phar. Innovation, Chris Latoz  & Lori shared by email 3/19, 3/20  to Stats/Stability list  
• Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes  - AAPS journal 2024  

4. Reminder: Topics for 2024 PharmSci 360 Submission  

• Proposal Submission deadline Apr 8; Rapid Fire  14June;  Call for proposals posted on Stability Community  

• One topic identified at Jan meeting – Manvi Hasija;  
• Others?

• Stability Community work with IQ Consortium to have a symposium at  AAPS – Lori/Kim/Manvi 

5. Increasing Member engagement: webinar and/or virtual discussion once per Quarter

Use one Stability monthly meeting slot for webinar and virtual discussion. 

a) Virtual Discussion (2Q):  at 9^th May Stability meeting 

• In-Use Stability Topic  identified - 5-6 discussion/focus points within topic (or benchmarking; Mini-case study)
• Summary 2 weeks (few focused topics)  prior – post and publicize to AAPS community; cross-post on communities

§  Zoom meeting; post in Stability Community & CMC Community, AAPS LinkedIn 

§  Dan, Sherilyn + Community member  - Moderators/Expert

2. Webinar in 3Q:  

• suggestions for topics/presenters – All
  • controlling the operations- temperature of the trucks or the monitors instead of qualify every single shipping route?
  • perform risk analysis: shipping trucks break down and justify the study they perform.   
  • Any recent poll about shipping best practices? 
• e.g. discussion of ICH Q14 ; or Mini-case study from Jan WCBP
• similar to KENX San Diego  -
• Stability aspects of ADCs – jointly with Sterile Product Community , 2-3 webinar series  
• Shipping - USP chapter and recent articles - which studies are necessary vs good to have- Nanda interest in webinar setup/Kim suggest speaker 

6. Sterile Products Community (if SPC members can join, Hitesh, Haresh, Yogita)

• Discussion on further collaboration : co-sponsor a presentation/ discussion with broader invitations
• Hiten/Haresh proposed a similar webinar for this year. Focus on "stability aspects of ADCs" it could be a series 2-3 webinars if needed. 
   

7. Joint Quarterly Stability-Stats Community 

- Reminder: Joint meeting with CMC Statistics Community: Lori/Kayla/Laura 

• 2Q:  Reference standard (RS) and use of long-term stability data to support requalification of RS  - Helen Strickland from Stats;  Stephanie Ferrari  for Stability   (Nanda is backup)
• 3Q: Comparability Part II   - Dan W. for Stability; Stats - Aili Cheng
• 1Q24: Use of means vs individual values to evaluate stability data  - Kayla Woodlief and Ben Ahlstrom – Completed - thanks!

  Microsoft Teams meeting

Join on your computer, mobile app or room device Click here to join the meeting<https://teams.microsoft.com/l/meetup-join/19%3ameeting_NWUxZjY4ZGQtOGFlYy00ZmQ3LWFlZTctZDNjMzM3MzM4Yjdl%40thread.v2/0?context=%7b%22Tid%22%3a%221ad4c8f9-44ec-4870-9515-b42d64d49a4e%22%2c%22Oid%22%3a%220e166dbd-aa42-4622-9bb8-46a8a0178822%22%7d> Meeting ID: 282 196 477 610 Passcode: 869yNv

Dear Community, 

Please feel free to join our upcoming Stability and Stats Community Joint Quarterly Meeting - Thurs Mar 14, 1:30-3PM CT.

The discussion will be on "Use of means vs individual values to evaluate stability data", led by Kayla and Kayla Woodlief & Ben Ahlstrom.

Thanks

Join on your computer, mobile app or room device Click here to join the meeting<https://teams.microsoft.com/l/meetup-join/19%3ameeting_OTAzZTI4MzItZTU4Ni00MTZiLWIxZTUtN2ZhOTlmYzExMzkw%40thread.v2/0?context=%7b%22Tid%22%3a%22db08e4ba-c0c6-4893-8bbe-8f3b86b87652%22%2c%22Oid%22%3a%22f015f740-a2e5-4432-9de8-4124e7badfeb%22%7d> Meeting ID: 214 804 895 523 Passcode: Lbmwgo Download Teams<https://www.microsoft.com/en-us/microsoft-teams/download-app> | Join on the web<https://www.microsoft.com/microsoft-teams/join-a-meeting> Or call in (audio only) +1 630-733-8283,,512233497#<tel:+16307338283,,512233497#> United States, Big Rock Phone Conference ID: 512 233 497#

Contact Vinaya Kapoor or Sherilyn Campie if you need the Teams link