Posted by Jonathan Winkel

Back in December when the FDA completed its initial discovery phase for coming changes to nutritional labeling, we wrote a blog post about the increasing frequency with which regulatory labeling changes will take place going forward. It addressed the impact that regulatory mandates in various jurisdictions can have on global companies and asserted that process automation will be the key to efficiency, productivity and market opportunity.

As we began to create a webinar series for packaging professionals, we decided that a good first topic would be to build on the subject of that post, share information on processes for managing global regulatory complexity and demonstrate how one global company has actually addressed regulatory labeling issues on a worldwide basis.

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About the Webinar

Following is some info about the webinar and why it’s important for all executives involved in global packaging to attend.

The webinar, titled, “Packaging & Global Regulation: Prepare to Manage Change or it will Manage You,” is taking place on Thursday, May 28th from noon ‘til 1 p.m. EDT. The company – Johnson & Johnson – will share a case study on the project it titled Cocoon. We believe this is one of the best examples of a successful global packaging compliance initiative.

J&J’s Manager of Global Regulatory Compliance Mario Portilla will be on hand to tell us about it. I’ll be moderating and making the case for one global workflow. Jagadish Katikalapudi, VP at our partner Freyr, will compare in-house services with shared services strategies.

Global Regulatory Management is Critical

Why is this an important webinar? Because implementing one global workflow for regulatory compliance is difficult and will likely become more so as global consumerism increases and the need for safety/sustainability protections proliferates. The webinar will help make it easier for you and your company to develop a workable plan to stay ahead of the curve.

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At this point, let me share a definition of ‘one global workflow’ and – to further describe why you should attend the webinar – some of the impediments to creating one. On the 28th, we’ll be offering ways to overcome these.

The definition is simple. One global workflow: One global regulatory review and approval process. Period.

One Global Workflow: Issues to Overcome

The implementation for most companies we know of is not so simple. Here are some of the key hurdles.

  1. Good old silos and varying regional requirements. There’s much discussion today about siloes within enterprises impeding collaboration and innovation and making multi-departmental initiatives sluggish. Multiply this silo effect by geographical turf spread around the globe where legal requirements differ and local relationships may run deep. Somehow silo walls must come down to unify the regulatory review and approval process. This is one of the most difficult parts.
  • For example, what happens if you set up a global process where marketing has the final review, but a regional/governmental jurisdiction requires that regulatory has the final review? In that jurisdiction, regulatory would be required to review in its turn according to the ‘one global workflow’ and again at the end to meet local standards – additional work for that group. This kind of special circumstance can lead to local complaints. Can these be accommodated?
  1. Disparate Technology. In most global companies a variety of technology systems from diverse vendors are in use region-by-region or country-by-country. Everyone is comfortable with their own system and no one wants to change and have to learn a new system. How can you overcome this?
  2. Language Barriers to Adoption. This is an obvious issue. When it comes to technology, strides have been made toward a language agnostic system. Notes can be in multiple languages, for instance. But software is not 100 percent there yet. Probably within the next five years software will catch up to language realities. What can you do in the meantime?
  3. Executive Buy-in. Someone with a high-level responsibility for packaging has to make the strategic and business case for such an initiative. (Of course, if the role of Chief Packaging Officer existed, it would be the CPO.) That executive has to validate the cost and get all key players to align on requirements. He or she has to gain buy-in regarding what the process should be. Where to start? Where to end? What are the connection points? What’s the ideation process? Do you do a mock-up?
  4. Implementation. That’s what J&J is going to share on the webinar. Again, it’s Thursday, May 28th from noon ‘til 1 p.m. EDT. Sign up here. We encourage you to join us to get answers to the questions above and to learn how to move your own initiative forward.

 

If you have additional thoughts or questions that you’d like us to address in this or a future webinar, please share those with us in the comments section. We look forward to your participation.


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