Mock Regulatory Inspections

One of the most gut wrenching moments in our industry is when the call comes from reception “the FDA is here and they want to inspect us”.   Your quality and regulatory team have worked hard and they say we are ready, but how can you be sure…

Having Horizon Phoenix conduct a Mock Regulatory Inspection is a good way to:

1. Determine your true level of compliance to regulations, Standards and other agreements.
2. Establish your readiness for the real thing well before the real thing happens!
3. Provide a training experience under the duress and intensity of a real inspection.

Common inspection findings; do any of these sound familiar?

Your team will grow with the experience and knowledge they will gain providing likelihood that the actual inspection, whether by Regulators or Customers, will go very well indeed.

Why partner with Horizon Phoenix to conduct my mock inspection?

• Meaningful, cost effective expertise is readily available on every manufacturing process from high volume injection molded parts to complex drug/device combinations; nutraceuticals; software; tissues for transplantation; and consumer products.
• Unique manufacturing processes such as aseptic filling or clean rooms and the challenges they present – no problem!
• Hands on experience with start-ups to multi-national corporations; federal/state/provincial agencies and non-governmental organizations such as ISO, IEC, the UN and WHO
• Comprehensive understanding of the research and development process; manufacturing; repair/warranty and customer service; we know what drives businesses to success and can readily identify warning signs of failure
• Every Horizon Phoenix partner or associate is an accredited professional, consultant and/or auditor with not less than ten years of experience AND have been in the trenches running companies, providing goods and services and cultivating intense customer loyalty, and lastly
• We have a keen and finely tuned perspective on the marketplace, the technology being used and the regulatory processes governing your compliance

The Mock Inspection will be conducted using our two hat methodology; first hat as the mean spirited inspector but also a second hat mentor to help raise acceptance by teaching why things are important and improving compliance through acceptance and understanding.

Our approach is entirely unique to your needs and expectations; there are regulations to be sure but we have no template reports to cut and paste or cookie cutter fill in the blanks forms.

What benefits can you expect from a Horizon Phoenix Mock Regulatory Inspection?

Considerably more than simply understanding your level of compliance!

1. Identify weaknesses or bottlenecks that increase your costs
2. Distinguish robust elements from onerous burdens
3. Cultivate confidence and a can do attitude in your team
4. Assessment of what other markets your current approvals and data could allow you to sell to.
5. New ideas, options and alternatives for your consideration and lastly
6. For every shortcoming identified there will be recommendations tailored to your product line and business environment.

What is covered by a Horizon Phoenix Mock Regulatory Inspection?

In a word, everything!  Every process (every rarely used ones); every document; every quality record and every product you make.  In these areas we will endeavor to examine 100%, not merely a sample.  Lastly before the Mock Inspection is concluded we will give you a chance to wash your dirty laundry by discussing in great detail areas you suspect are weak.

A Regulatory Inspection is never an easy thing to endure but the experience and knowledge gained through a Horizon Phoenix Mock Inspection will prepare you and make the real thing much less traumatic.  By creating a learning experience that accurately simulates an inspection, an organization can test its response procedures and bolster employee knowledge and confidence to handle a real inspection more effectively.

Ask us how this can work for you…