ASQ Boulder 2025-Feb-18 Section Web Meeting

Topic: What is Pharma FDA 503B? (Outsource Compounding Facilities)
Cost: Free
Note: Tuesday 5:45pm to 6:55pm US-MT meeting

Note: Joint Meeting with Pikes Peak (Colorado Springs CO) Section
RSVP on Boulder Section’s meeting "Meetup Link"
https://www.meetup.com/boulder-quality-meetup/events/305117566/
RSVP note: Please provide your Name and Hometown. Same for any guests
5:45 pm Web Conference Start: Networking, Welcome and Section Business
6:00 pm Presentation

• Speaker: Anil Mathai https://www.linkedin.com/in/anil-mathai-0ab1436/
• Topic: What is Pharma FDA 503B? (Outsource Compounding Facilities)
• Note: Recording and slides only access via ASQ National Membership
• Note: Non-ASQ Members please contact Arnold Miller via amiller@memberleader.asq.org to get slides 
• Presentation recording at https://my.asq.org/viewdocument/2025-02meeting-503b-outsource-compo-1
• Presentation Slides at https://my.asq.org/viewdocument/2025-02meeting-503b-outsource-compo
• Abstract:
  • Learn about FDA 503B "How Compounders Become an Outsourcing Facilities"
  • What is Drug Compounding?
  • History of Drug Compounding
  • Why Compound Instead of Mass Manufacture?
  • What is a 503B Facility?
  • These 503B Outsourced Facilities must
    • Comply with CGMP requirements;
    • Be inspected by FDA according to a risk-based schedule;
    • Meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
• Bio: Anil Mathai,  BSChE, MBA, LSSBB, CQA
  • Anil Mathai is the International Society for Pharmaceutical Engineering’s (ISPE) Pharmaceutical Compounding Community of Practice Chair.
  • He has over 28 years of experience, working with companies such as KMI/Parexel, Centocor (Johnson & Johnson), Schering-Plough, Merck, Bonfils Blood Center (Vitalent), Jubilant, and STAQ Pharma.
  • Anil provides leadership on strategy, vision, & development of Quality Systems to ensure adherence with customer & regulatory expectations.
  • He is currently performing consulting work via Global Light Enterprises LLC.
  • He is a member of American Society for Quality (ASQ), Parenteral Drug Association (PDA), formerly RAPS, etc.
  • He has been a His passion for ensuring safe product gets to the patient in a timely manner, for mentoring his colleagues to grow daily, and for continuous improvement are what bring him joy professionally.
  • He is a graduate of Drexel University (BSChE) & Pennsylvania State University (MBA), with a CQA & LSSBB.
  • Anil is passionate about building better trust-based relationships, solving problems, helping & encouraging people, and increase revenues.
• References:
  •  Web-Site: FDA Drug Compounding FAQ 
  • Web--Site: FDA Outsource Compounding Facilities 

6:50 pm After Presentation Networking
6:55 pm Web Conference End: meeting over
Place: Web Conference Webex

• Meeting link: https://asq.webex.com/asq/j.php?MTID=m8d6f9d4be23627a26a4b67b2e24aa204
• Meeting number: 2553 040 4741
• Password: VxyNSezS444

Meeting also posted on ASQ Boulder Meetup's 18 Feb 2025 meeting