For Life Sciences organizations, there has never been a debate around the criticality of data quality and regulatory compliance.  However, for Consumer Products companies, it is often a much greater challenge to gain alignment around the strategic imperative of quality.  Consider the following:

• Many companies are managing quality data throughout the organization — specifically the supply chain and distribution channels — without leading processes and systems, which is setting organizations up for escalating quality costs and efficiencies when the FDA appears.
• The number of class action lawsuits against consumer products companies for alleged poor labeling and marketing practices continues to rise. With so much uncertainty around marketing claims, the consumer products industry faces insecurity in their regulatory strategy, particularly around labeling, leading to costly lawsuits and settlements, packaging and labeling rework, excess inventory, and loss of consumer goodwill.
• The FDA has placed greater scrutiny on health-related products that are being introduced to market to meet the needs of a more health conscious consumer.  This new regulatory oversight places significant focus on validation so investing in a sound process now will pay dividends in the future for your compliance position.

Regulatory Compliance and Data Quality

In this week’s Taking Stock, I am excited to be joined by Rob Wojtowicz and David Patterson.  Rob is a Manager in our Quality & Regulatory practice and has spent the past few years focused specifically on improving data integrity and compliance with leading cosmetic and consumer products organizations.  David is the lead of our Consumer Products Quality & Regulatory Community and is a thought leader in the industry around the strategic imperative for quality within CP companies.

In our discussion, we will discuss why CP organizations often struggle in defining what their quality strategy should be.  From the challenge of a one-size fits all approach due to their complex and diverse product portfolios to finding the right balance between quality compliance and speed to market, Rob and David will share their perspectives on what is ‘good enough’ for CP companies and strategies they should deploy to ensure quality is maintained without sacrificing competitive advantage.

You can download and listen to the Regulatory Compliance and Data Quality : Taking Stock with David Patterson and Rob Wojtowicz here.

Taking Stock

In this podcast series, Clarkston Consulting Partner Steve Rosenstock sits down with experts and thought leaders from both within Clarkston and throughout its consumer products and life sciences client-base, covering a range of topics from industry trends and consumer dynamics, to organizational governance and business strategy. Steve provides you access into the passions of its guests and allows you to benefit from their stories, knowledge, and deep expertise.

Additional contributions by Rob Wojtowicz. Podcast production by Zach McClughen.