ComplianceOnline

Key Factors to Set Up Excursion Studies to Support Commercial Products

Instructor: Kim Huynh-Ba
Product ID: 704421
  • 27
  • September 2017
    Wednesday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 90 Min

Live Online Training
September 27, Wednesday 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Min

$229.00
One Dial-in One Attendee
$459.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.

Why Should You Attend:

Current GMP requires organizations maintain label storage condition of drug products throughout the supply chain as part of the Quality Management System (QMS). Regulations and guidelines in this area are not well defined, yet pharmaceutical companies must take necessary steps to maintain quality of commercial products during transport and distribution. Most organizations focuses on the efficacy of the products, but this is rarely the concern. The increase of degradation products or new impurities is the main issue when materials are not stored and shipped according to their label.

Transportation of pharmaceutical products could involve long and complex routes that may require temperature controlled environments and issues such as temperature excursions, packaging breakdowns, incorrect shipping or custom delays could cause detrimental effects and cause loss of product sales. Therefore, it is a challenge to balance between the additional cost of shipping and the product quality.

This webinar will discuss the complexity of the storage and distribution of pharmaceutical products and the effect of environmental factors during transportation and distribution and key factors to be considered to set up temperature-cycling studies to support excursions during shipping of pharmaceutical products depending on their label storage conditions.

Areas Covered in the Webinar:

  • Understand the complexity of transporting and distributing of clinical and commercial products
  • Goal of stability studies and environmental factors
  • Different modes of shipping and distributing of products
  • Risks encountered during transporting and distributing pharmaceutical products
  • Temperature cycling studies to support shipping and storage excursions

Who Will Benefit:

  • Analytical chemists
  • QC managers
  • QA managers
  • Compliance managers
  • Lab managers
  • Sale managers
  • Distributors and manufacturers of raw materials and ingredients
  • Personnel who are responsible with transporting and distributing products through the supply chain
Instructor Profile:
Kim Huynh-Ba

Kim Huynh-Ba
Founder and Technical Director, Pharmalytik

Kim Huynh-Ba, has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.

Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and will be their 2013 President. She is the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP Impurities of Drug Products Expert Panel (2012-15). She was also a member of USP General Chapter Expert Committee (2010-15), member of USP Reference Standard Project Team and USP Prescription/Non-Prescription Stakeholder Forum of previous cycle. She was a member of the Consumer Healthcare Product Association’s (CHPA) Stability and Impurities Breakout Groups. Kim currently is a member of AAPS Publication Committee, Chair of the Stability Focus Group and serves on the Steering Committees of CMC and Pharmaceutical Trace Impurities Focus Groups. Kim is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award.

Kim has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the "Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices" (2008) and "Pharmaceutical Stability Testing to Support Global Markets" (2010).

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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