Purchasing Controls for Medical Device Manufacturers: Complying with Stepped Up Enforcement of 21 CFR 820.50 and GHTF/SG3/N17R9:2008
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It’s only 197 words long, but woe to the device and diagnostics manufacturer who fails to pay attention to 21 CFR 820.50.
It’s required reading ... unless you prefer reading a warning letter.
The FDA’s purchasing controls regulation, along with GHTF/SG3/N17R9:2008 — commonly known as Guidance on the Control of Products and Services Obtained from Suppliers — have turned into headaches for the entire device and diagnostics community, including OEMs, contract manufacturers, even supplier of raw materials, as device regulators including the FDA, the EMA and others toughen up on supply-chain issues.
And there’s been a significant increase in the number of related warning letters like this one:
Sept. 8, 2010 — CeraSys, Incorporated
“Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, and to maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants as required by 21 CFR 820.50(a) …”
But, you can clean house … get up to speed … and avoid being the next to get a warning letter ... all in just 90 minutes. Here’s how.
Register now for the upcoming FDAnews webinar, Purchasing Controls for Medical Device Manufacturers, and you’ll gain the information and knowledge you need to meet these key requirements:
- Establish defined procedures for purchasing controls
- Create categories of suppliers
- Ensure that your quality process is clearly defined, and
- Document all records of purchasing controls.
So much for generalities. Now, let’s get down to specifics of what we’ll cover:
- What the FDA is looking for, as revealed in 483s and warning letters
- How to manage supplier qualifications via both approved and unapproved suppliers lists
- How to create and maintain documentation of purchasing control events
- Understanding change control — how to ensure you maintain a state of control within your supply chains
- Writing and enforcing SOPs that clearly define processes for supplier changes
- How to establish categories for suppliers to support risk assessment and management
- And much more!
Your instructor, Dan O’Leary, has more than 30 years experience in quality, operations, and program management in regulated industries. In this information-packed 90-minute session, he'll walk you step by step through the processes and procedures your company must implement to stay squeaky clean.
The Purchasing Controls for Medical Device Manufacturers webinar is convenient to attend. All that’s required is that you be in front of a computer monitor at the appointed time, whether you’re at the office or telecommuting from your office-in-home.
Of course, Mr. O’Leary will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in purchasing will benefit from taking part in this event — and they can do so at a cost that won’t break your budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.
Regulatory oversight of global supply management will only grow tighter in the years ahead. Don’t risk sanctions — not when help is at hand.