Regulatory and Quality Assurance | Michelle Lott | lean RAQA

Food

Your “best by” date?

I’m thinking your best-by launch date is now, please?

There’s an unfortunate number of food-based puns we could make, but wouldn’t want to spoil your day!

But this might:

That recent Food Safety Modernization Act is a killer. You probably don’t want to be an expert in it. That’s when you call us.

Because you needn’t be an expert in it.

Just having smart friends on hand is better. And less expensive.

Check Out All These Flavors:

21 CFR 1271.265(f)

Return to inventory – procedures

21 CFR 1271.47(a)

Donor eligibility procedures

21 CFR 1271.47(a)

Procedures for all steps

21 CFR 1271.320(a)

Procedures re complaints

21 CFR 1271.265(e)

Procedures and release criteria

21 CFR 1271.75(e)

Abbreviated procedure

21 CFR 1271.230(a)

Process validation procedures

21 CFR 1271.190(d)(1)

Procedures for cleaning, sanitation

21 CFR 1271.200(c)

Calibration procedures and schedules (general)

21 CFR 1271.230(a)

Validation & approval – established procedures

Shall I Continue?

No, you get the idea. I hate to see bad things happen to companies doing good, important work.In my storied (indulge me) career, I’ve seen one too many “If only so-and-so followed the procedure, we could have avoided this” messes that cratered otherwise-promising technologies.

Call me so you can avoid the same fate. Please?

call me

Consider yourself a foodie, eh?

Well, then you should know the answers to these savory questions!

  • 1. What type of food businesses are subject to FDA regulation?
  • 2. What types of good manufacturing practices apply?
  • 3. What is a HACCP and do I have to complete one for my product?
  • 4. What is the Food Safety Modernization Act and how will it impact my business?
  • 5. What are the labeling requirements for my product?
  • 6. What type of information do I have to have to make claims such as “gluten-free,” ”organic,” or all natural?
  • 7. What records must I maintain for my food products? For how long?
  • 8. What organizations besides FDA my regulate my food product?
  • 9. What types of foods have additional product-specific regulatory requirements?
  • 10. What type of testing must I conduct on my product?

I promise I’ll spare you the food puns.

🌟 10: You’re a superstar.

What are you doing here? You’ve totally got this.

💪 9: Impressive!

How can I complement what you’re already doing?

😬 8 or fewer…

To be safe, put time on my calendar. “Too proud to ask Michelle” is no reason for a 483 or warning letter. Plus I like meeting new people!

Help Has Arrived!

Pick an open half hour on my calendar. Maybe I can lighten your workload and I would LOVE to help!

let’s connect!