Latest Fda regulations Podcast Episodes
DHF & Design Control
RCA Radio - July 26, 2022 15:00 - 14 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Jessica Schafersman, Biomedical Engineer, Project Management Professional, and Certified Usability Analyst at Regulatory Compliance Associates® (RCA) to talk about Design controls and the proper way to go about developing your DHF fo...
Growing Cannabis Businesses With People, Processes and Technology
Take Me to the Cloud - July 19, 2022 19:00 - 9 minutesThe medical and recreational cannabis industry has emerged into segregated markets providing various business opportunities. Withum’s Management Consulting Team Members Walter Merkas and Kim Gordon dive in headfirst to discuss the operational facets of cannabis. From maturity models to complianc...
Solving the Implementation Challenges of Omnichannel
Take Me to the Cloud - June 15, 2022 18:00 - 11 minutesOmnichannel customer experience has become the next big step in the e-commerce roadmap. It may sound daunting initially, but planning ahead and setting achievable goals is the key to success. Listen in as Wally Merkas, Melanie Saunders and Wendy Lin of Withum's Management Consulting team share t...
What is Irritation and Sensitization?
RCA Radio - June 10, 2022 20:00 - 27 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Audrey Turley, Matt a board-certified toxicologist with a Ph.D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Audrey is a Nelson Labs Senior Biocompatibility Expert. Listen i...
Outsourcing and Staff Augmentation
RCA Radio - May 26, 2022 19:00 - 14 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Erica Porcelli, CEO of Regulatory Compliance Associates® (RCA), to going to over outsourcing leadership roles and how companies use staff augmentation to jump-start their teams. Listen in as we talk about what outsourced leadership ...
Ensuring A Smooth, Successful Month-End Close
Take Me to the Cloud - May 16, 2022 12:00 - 9 minutesMany small to medium-sized businesses experience pain points in their financial close processes. A long, drawn-out process results in accounting and finance teams running on a proverbial hamster wheel. Withum’s Management Consulting team members Melissa Holton and Chris Higgins discuss the value...
What is ISO 13485?
RCA Radio - May 03, 2022 15:00 - 13 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory Compliance Associates (RCA) to cover the Medical Device quality standard ISO 13485 and why it is important for the industry. Listen in as Jordan goes over the background of ...
Risky Business: Proactive Risk Management Strategies
Take Me to the Cloud - March 30, 2022 20:00 - 25 minutesRisk management is not a simple checklist, but rather a dynamic system of processes that work and live together to provide conscious awareness. Listen in as Brad Smolen, Joe Riccie and Jones Yiu from Withum's Management Consulting team discuss their experiences with risk management. They will al...
Robotic Process Automation Isn't Replacing You, It's Enhancing You
Take Me to the Cloud - March 08, 2022 15:00 - 26 minutesThere was a time when we thought Robotic Process Automation would replace our jobs. In this episode, Joe Riccie welcomes Wilton Rogers III, Founder, President and CEO of Simply Automate to debunk that theory and share how automation is your pathway to modernization and innovation.
Distribution in the Face of Disruption
Take Me to the Cloud - February 23, 2022 15:00 - 16 minutesFrom accelerated digitization to expanded competition, numerous disruptive forces affect distributors. Kim Gordon welcomes Chris Higgins and Luis Palmitesta to discuss how consumers drive the market today. Hear how distributors use analytics, e-commerce and CRM technologies to institute new busi...
What is Cytotoxicity?
RCA Radio - February 21, 2022 23:00 - 30 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel, Matt a board-certified toxicologist with a Ph.D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Helin is Nelson Labs Senior Biocompatibility Expert with a Ph....
2022 Industry Outlook - Pharmaceutical
RCA Radio - January 25, 2022 14:00 - 22 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller and Steve Lynn, who is Regulatory Compliance Associates® Inc. (RCA) Executive VP of Pharmaceuticals, explore what is happening in the Pharmaceutical industry in 2022 and provide you with insight on how to prepare yourself for these upcoming ini...
Intro to Pre-Clinical Testing and Biocompatibility
RCA Radio - January 20, 2022 15:00 - 32 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel, Matt a board-certified toxicologist with a Ph.D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Helin is Nelson Labs Senior Biocompatibility Expert with a Ph....
The Benefits of Resource Management Planning and Tips to Consider
Take Me to the Cloud - January 14, 2022 16:00 - 20 minutesAs the new year kicks off, it is time to ramp up your resource management planning (RMP). Our Management Consulting team discusses the basic principles and shares how RMP can benefit your organization in this episode. Tune in as Brad Smolen, Joe Riccie and Jones Yiu speak about their experiences...
The Benefits of Resource Management Planning and Tips to Consider
Take Me to the Cloud - January 14, 2022 16:00 - 20 minutesAs the new year kicks off, it is time to ramp up your resource management planning (RMP). Our Management Consulting team discusses the basic principles and shares how RMP can benefit your organization in this episode. Tune in as Brad Smolen, Joe Riccie and Jones Yiu speak about their experiences...
2022 Industry Outlook - Medical Device
RCA Radio - January 04, 2022 15:00 - 32 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller, Seyed Khorashahi, and Thor Rollins explore what is happening in the medical device industry in 2022 and provide you with insight on how to prepare yourself for these upcoming initiatives. Seyed is Regulatory Compliance Associates® Inc. (RCA) Exe...
Why Financial Visibility Is Your Key to Success
Take Me to the Cloud - December 01, 2021 15:00 - 6 minutesIn this episode, we welcome back Tom Burns and Christian DiRusso from Withum's Management Consulting Team. They break down the importance of financial visibility and how your organization’s management can work together to improve it. Hear their take on current challenges and what tools are deeme...
What You Need to Know About Our App-Centric Economy
Take Me to the Cloud - November 10, 2021 14:00 - 7 minutesWithum’s Management Consulting team members Tom Burns and Christian DiRusso discuss what app-centricity is and what our app-centric economy looks like today. The vast, ever-growing marketplace of software tools and ERP applications is exciting but can be intimidating. Tune in to learn about the ...
Laboratory Out-of-Specification Investigations
RCA Radio - November 09, 2021 15:00 - 29 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Senior Director of Quality Control and Consulting Services, Walter Mason, take a deep dive into laboratory Out-of-Specification (OOS) investigations and how to get to the root cause. Listen in as we g...
Case Study: Quality Complaint Investigations
RCA Radio - October 26, 2021 14:00 - 10 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Senior Director of Quality Control and Consulting Services, Walter Mason, go over a case study where we tried to teach a client that received a warning letter life lessons for Quality Complaint investi...
Pros and Cons of Point Solutions
Take Me to the Cloud - October 15, 2021 13:00 - 11 minutesIn this episode, Kim Gordon is joined by Walter Merkas and Jones Yiu from Withum's Management Consulting Team. They discuss what point solutions are and their advantages and disadvantages for organizations. Listen in as they break down the big picture of this specialized software and compare i...
Case Study: Warning Letter Remediation
RCA Radio - October 12, 2021 14:00 - 11 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Executive VP of Pharmaceuticals, Steven Lynn go over how RCA helped an international company perform a gap analysis based on multiple FDA investigations. Listen in as we break down the client's Warnin...
What Makes a Great Quality Management System
RCA Radio - September 22, 2021 14:00 - 14 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, guest host Dean Coston and Susan Schniepp, Regulatory Compliance Associates Inc.'s (RCA) Distinguished fellow go over how the people, processes, and documentation all come together to make a Quality Management System. About RCA Regulatory Compliance Associates® ...
Innovation in Accounts Payable: Why Consider Payment Automation?
Take Me to the Cloud - September 17, 2021 18:00 - 30 minutesWithum’s Joe Riccie welcomes Finexio’s Founder and CEO, Ernest Rolfson as they discuss today’s payment challenges in multiple industries and controls and why traditional payment processes are slowing down operations and causing lost labor time. They provide feedback on benefits of B2B electron...
Design of Protocols for Biologics
RCA Radio - August 31, 2021 19:00 - 43 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller, Steve Lynn, and Walter Mason, (Regulatory Compliance Associates Inc.'s (RCA) Executive VP of Pharmaceuticals, RCA's Sr. Director of Quality Control and Consulting Services) go over the design of biologic protocols, the importance of keeping data...
Design of Protocols for Biologics
RCA Radio - August 31, 2021 19:00 - 43 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller, Steve Lynn, and Walter Mason, (Regulatory Compliance Associates Inc.'s (RCA) Executive VP of Pharmaceuticals, RCA's Sr. Director of Quality Control and Consulting Services) go over the design of biologic protocols, the importance of keeping data...
Key IT Due Diligence Considerations for Mergers and Acquisitions
Take Me to the Cloud - August 10, 2021 21:00 - 12 minutesConsidering a merger or acquisition? In this episode Kim Gordon and Wally Merkas discuss M&A activities from the buyer side when it comes to IT due diligence. What should the acquirer think about regarding their target’s IT systems? How to they assess and mitigate overall risk of the acquisiti...
3 IT Due Diligence Considerations for Buyers During M&A
Take Me to the Cloud - August 10, 2021 21:00 - 12 minutesConsidering a merger or acquisition? In this episode Kim Gordon and Wally Merkas discuss M&A activities from the buyer side when it comes to IT due diligence. What should the acquirer think about regarding their target’s IT systems? How do they assess and mitigate overall risk of the acquisiti...
Flexibility and Functionality of Headless Commerce
Take Me to the Cloud - July 14, 2021 12:00 - 11 minutesIn this episode, featuring our guests Dave Crouch and Brad Gustavesen from Slatwall Commerce, we look at headless commerce and the functionality and flexibility it provides to B2B ecommerce. Take a listen to learn what headless commerce is, how you can leverage existing systems without having ...
Why Distributors are Going Digital
Take Me to the Cloud - July 14, 2021 12:00 - 10 minutesDave Crouch and Brad Gustavesen from Slatwall Commerce join Kim Gordon and Wally Merkas to talk about the pressure distributors are facing to go digital. Mid-market distributors and manufacturers are struggling to get information on the supply side and the demand side as customer expectations ar...
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