Click the links (in blue) below to view the Slideshow presentations:
The February membership meeting is at
Pre-Meeting Presentation 5:30 – 6:00 pm
Dinner, Networking 6:00-7:00 pm
Main Presentation 7:00 – 8:00 pm
Reserve your spot by filling out the Eventbrite form at the end of this announcement.
Members seeking employment are eligible for the courtesy dinner. Be prepared to show your membership number.
Presentation Topic: Taking the Mystery out of Computer System Compliance
Many Quality Assurance professions are confident in their QA expertise for a wide array of topics, including manufacturing, laboratories, clinical trials, and QMS, but start to feel uncomfortable when computer systems are the focus.
The aim of this presentation is to increase the comfort level on the subjects of computer system validation and electronic data integrity by answering these questions:
- What is Computer System Validation (CSV)
- Why should you perform CSV
- Which systems need to be validated
- What are the steps of the CSV process
- What do you need to do to ensure the integrity of electronic data
Biography: Deb Bartel is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice. She is a long-time leader of software quality and information system initiatives with over 25 years of experience in multiple industries, including pharmaceuticals, medical device, chemicals, and textile manufacturing.
Deb has great enthusiasm for applying practical, effective approaches to meet the quality and compliance challenges of the Life Sciences industry. She has been able to use LEAN, continuous improvement, and risk-based processes to reduce costs while maintaining compliance with both US and international regulatory agency expectations. Deb also has many years of experience managing international ERP, laboratory, pharmacovigilance, clinical, quality management, and financial systems projects in both regulated and non-regulated industries.
Since joining Praxis in 2007, Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation. She also leads a popular weekly webinar series on CSV and SQA topics such as Part 11, Annex 11, Cloud/SaaS in GxP, and Auditing Software Vendors.
Deb has BS-Information Systems and MBA degrees from the University of Wisconsin. She holds ASQ certifications in quality auditing (CQA) and six-sigma processes (CSSGB) as well as a PMP from the Project Management Institute.
During Networking Dinner:
CGMP and Postmarketing Safety Reporting Requirements for Combination Products
Jesse Vazquez from FDA Chicago district office will be present at our meeting to answer questions that our members may have. Jesse is a Medical Device Specialist (Biomedical Engineer / Investigator) at the Chicago district office. He Conducts inspections of regulated industry including inspections related to product marketing applications. Investigates complaints of injury, illness, or death caused by a product regulated by the FDA. Trains and works with industry, State and local officials, consumers, and fellow colleagues on enforcement policies, methods, and interpretation of FDA regulations and their impact on public health. Combination products such as drug-coated devices, prefilled delivery devices, convenience kits and cross-labeled products, raise a variety of unique regulatory issues. This presentation will focus on the current good manufacturing practice (CGMP) and very recently issued postmarketing safety reporting requirements for combination products. We will review the underlying CGMP and postmarketing safety reporting requirements for drugs, devices and biological products, and the final regulations now in place that specify the additional requirements that manufacturers must implement for their combination products. Key takeaways from each regulation including compliance timeframes, enforcement considerations and recommendations will also be addressed.
Combination products such as drug-coated devices, prefilled delivery devices, convenience kits and cross-labeled products, raise a variety of unique regulatory issues. This presentation will focus on the current good manufacturing practice (CGMP) and very recently issued postmarketing safety reporting requirements for combination products. We will review the underlying CGMP and postmarketing safety reporting requirements for drugs, devices and biological products, and the final regulations now in place that specify the additional requirements that manufacturers must implement for their combination products. Key takeaways from each regulation including compliance timeframes, enforcement considerations and recommendations will also be addressed.
Mark D. Kramer, MS, RAC, is President, Regulatory Strategies, Inc., (www.regulatorystrategies.net), a regulatory consultancy specializing in medical devices and combination products. He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration, culminating in his position as Director of FDA’s Office of Combination Products from 2002 to 2007. Mark began his career in engineering and clinical/regulatory affairs positions in the medical device industry. He joined FDA’s Center for Devices and Radiological Health (CDRH) as a lead reviewer in the Pacing and Electrophysiology Devices Branch, and from 1990-1995 served as Chief of the Urology and Lithotripsy Devices Branch. He then went to the private sector, serving in both consulting and in-house corporate regulatory affairs capacities. Mr. Kramer returned to FDA in 1998 as Chief of CDRH’s Anesthesiology and Defibrillator Devices Branch until his appointment as Director, CDRH Staff College in 1999. He then served as Director of the Agency’s Combination Products Program from February 2002 until the establishment of the Office of Combination Products in December 2002, where he served as Director until April 2007. As OCP Director, Mark led the development of policies, procedures and processes to ease the assignment, premarket review and postmarket regulation of combination products. From 2007-2010, Mark was Vice President, Regulatory Affairs and Chief Regulatory Strategist at GE Healthcare. Mark served on the Board of Directors of the Regulatory Affairs Professional Society (RAPS) from 2009-2014, served as Chair of the Wisconsin RAPS Chapter from 2007-2010, and is an adjunct faculty member for St. Cloud State University’s Master’s program in regulatory affairs. Mark can be reached at email@example.com.