How To Get It Right The First Time
ASQ FDC SCDG Presents…
Thursday, August 23, 2012
5:30 p.m. – 8:30 p.m.
1 Baxter Way #100, Thousand Oaks, CA 91362
Speaker & Host: Mary Thorsness, Quality Manager – CAPA Division, Baxter BioScience
Mary graduated with a bachelor’s in Biology from the University of California at San Diego. Mary has been with Baxter since 2005 as BioScience Division CAPA Manager and is responsible for the division CAPA program in 15+ sites throughout the US and Europe. Among her responsibilities, Mary is a certified Lead Investigator trainer responsible for training potential CAPA owners, approvers, and other trainers. Prior to her current position at Baxter, was had extensive leadership experience in the biotechnology and medical device industries.
Which Data Streams You Should be Analyzing and How: There are an overwhelming number of data streams that can be analyzed and reported on. How do you sort the “essential” and focus on them? Do these reported data streams stay the same through the years, or do they evolve as your industry, company, and regulatory climate evolves?
This interactive session will identify which data streams you should use to gauge the health of your products and quality system and how to measure and report them in a way that will be understood by those who review them.
– Identify which data streams you should use to gauge the health of your products
– Identify which data streams you should use to gauge the health of your Quality system
– How to measure and report that data in a way that will be understood by those who review it
Speakers: Niedre Heckman, Manager – Regulatory Affairs, Baxter BioScience and Kumari Devulapalle, Chemist – 3M
Niedre Heckman is a Quality Management professional with nearly two decades of hands on expertise in quality assurance, quality control, regulatory affairs and research and development. She is a process oriented leader with diversity of experience across medical products. She couples experience in quality systems and regulatory compliance with business acumen to develop strategic solutions that achieve organizational goals.
Currently, Niedre works in Regulatory Affairs at Baxter Healthcare Corporation. Prior to this, she worked for 3M in Quality and in Regulatory Affairs positions.
Niedre is involved with the professional organizations ASQ and RAPS, where she holds the CQA and RAC certificates, respectively. Niedre has an MS in Chemistry from UC Irvine and an MPH from UCLA.
Dr. Kumari Devulapalle, has extensive experience in biochemistry and biotechnology both in academics and biopharmaceutical industry over 20 years. She has contributed to different NIH grants on enzyme kinetics and protein modeling during her work at University of Southern California before she moved to Amgen analytical R & D on method development and validation for therapeutic biomolecules.
- She has been working for the past 8 years at 3M Northridge, in quality control aspects of the biopharmaceuticals where she is leading the implementation of Six Sigma Lean projects. She is also known in adapting Right The First Time, analytical method improvements for product testing and release.
The majority of drug products are not discretionary and are often urgently needed. Depending on the type of product, for example biologics, shelf-life and storage factor into the urgency of getting products to the customer. Thus, there is a business need and responsibility to provide high quality products in a reasonable, and sometimes expedited, manner. This presentation considers best practices for getting drug products to the customer in two areas: (1) Product release of pharmaceuticals from the Quality Assurance Unit, and (2) Global product registration enabling world-wide product accessibility to customers. This audience interactive session will provide some dashboard metrics used to ensure processes for efficiently getting product to customers are tracked for continuous improvement. The session will also bring awareness to some of the interesting details that can slow down the process.
- General understand of metrics than can be applied to product release and product global expansion
- Tools that can be implemented in a high-volume quality control laboratory
- Awareness of how US compliance issues can slow down or stop global expansion
5:30 pm – Registration and Networking
5:45 pm – Dinner
6:00 pm – Welcome and Introductions
6:15 pm – Speaker: Mary Thorsness
7:00 pm – Break
7:15 pm – Speakers: Niedre Heckman and Kumari Devulapalle
8:00 pm – Q & A
8:15 pm – Evaluation and Raffle Drawings
8:30 pm – Adjournment
** Dinner is included with your registration. Register now at http://www.eventbrite.com/event/4024074114