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The Next Steps to Prepare for NERC’s FFT Reporting

October 17, 2011 By Leave a Comment

Vice President, Energy & Utilities Compliance, AssurX Inc.

To continue the discussion on NERC’s new compliance enforcement initiative – Find, Fix, Track and Report (FFT Report),  there are a couple important things to consider as this new process is implemented.

NERC and the Regional Entities (RE) will be watching and reviewing the registered entities on prompt self-reporting of the potential violation, risk associated with the discovered issue, and the mitigating activities; either ones completed or the tasks that are underway.  The Regional Entities will be assigning a unique tracking number for the self-reports as they do now.  What will now take place during their evaluation is the severity of the risk to BPS, and the time discovered by the registered entity to the time reported to the RE.  NERC and the Regional Entities still urge all registered entities to notify their region as soon as a possible violation is discovered.

Registered entities with a strong compliance program will identify the potential violation and investigate internally with the proper resources as quickly as possible.  They will take immediate corrective actions to mitigate the discovered issue.  The registered entity will enter the issue into their corrective action tracking system and disposition to appropriate individual/department.  Such tracking systems trend and categorize all level of issues to assist management with identification of trends and areas of improvement.  This might initiate an internal self-assessment or even a root cause evaluation if the level has been determined severe.

The initiative that was submitted to FERC on September 30, 2011, stated that the registered entity’s compliance program, mitigation and corrective action programs, internal controls and culture of compliance will have an impact on how the Regional Entities evaluate the potential violation.  Key elements to promote these internal behaviors within an organization are:

  • Effective identification
  • Objective self-assessments
  • Internal evaluations, tracking, fixing, and trending issues

Identification of even low-level issues can help prevent larger issues that could have a major impact on the BPS.  The proper environment that encourages employees to bring up and identify issues is an important step.  This can only be done if management fosters this environment and encourages and rewards employees for discovering issues.  Senior management that demonstrates this will be taking the proper steps for building a strong culture of compliance.

The next FFT Report blog post will discuss the importance of an internal self-assessment program looking at all aspects of a good compliance program to ensure that the registered entity build and maintain strong internal programs.

You can follow Trey on Twitter.

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Filed Under: Electric Reliability, Trey Kirkpatrick Tagged With: , , , ,

Protect Your Firm as FDA Inspections Spike for CROs, Sponsors

May 24, 2011 By 2 Comments

Patrick Stone, President, TradeStone QA

During the last two years of my time with FDA I noticed the amount of Sponsor and CRO inspections triple in number (for CDER, CDRH, & CBER).  CRO’s with less than adequately trained clinic staff and facilities to conduct human clinical trials are receiving warning letters and other FDA regulatory penalties.  The FDA has not conducted enhanced Sponsor or CRO Inspections in many years.  I have observed study sites get warning letters because monitors did not catch informed consent violations early in the trial or for other regulatory and subject record keeping violations.  Catching serious problems early in the trial can prevent adverse events, save time and assets in the long run.

Clinical Investigators and Sponsors  do not want to throw study data out due to preventable errors and inconsistent data.  Monitors for CRO’s and Sponsors should be proficient at the Quality Assurance (QA) they provide and be given adequate time at the study site to ensure regulatory and protocol compliance.

In my time at the FDA, even up to the end of my tenure this past March, I have observed CRO’s collecting original source site documentation from the clinic site at study close-out. I wonder how CRO’s seem to keep missing the basic reason FDA investigator’s conduct data-validation audits.  FDA wants to validate that source documentation match the case report form (CRF) and the sponsor provided data-listing with efficacy end points & adverse event lists.  CRO’s can easily scan the original documents into their system, but physically removing the source documents has conditions.

If a CRO truly wants the original documents for whatever reason, the CRO may certify each copy as a true duplicate of the original (21 CFR describes this process).  In many cases the Clinical Investigator relocates or there is no available space and money to store the records so the sponsor may step in to take over.  There’s not going to be any problem as  long as the FDA can follow the paper trail and review original documents as needed.   Copies may and have been found to be falsified so Investigators will not review paper copies of paper source records.  Electronic printout (output) is a different way to operate now and is acceptable for review.  Sponsors & CRO’s are using more electronic case report forms CRF’s & electronic records in general.  FDA is now requiring field Investigators to review computer systems for 21 CFR part 11 compliance & legacy system maintenance.

Do a search for your competitors’ recent FDA inspections and you will see the trend I am describing.  Build quality into your system from the ground up and you will get quality product results.  Trying to retroactively validate electronic systems and equipment or implement late stage corrections will leave you vulnerable to 483 observations.

You can follow Patrick on Twitter.

 

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Filed Under: FDA Regulated, Medical Devices, Patrick Stone, Pharma/Biotech, Regulatory Tagged With: , , , , ,

FDA Lifts Curtain on Inspection Process, Rationale

March 25, 2010 By 2 Comments
Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Gotta give the FDA some credit here. In addition to its transparency initiative we’ve talk about before, the agency is also trying to remove some of the mystery about how it handles inspections and other inner workings at the FDA. From where I sit, it appears to be a sincere effort and I believe it is helping outsiders better understand what the FDA is trying to do – and how it is trying to do it.

For example, at the second in a new series of monthly online webinars, FDA’s Michael C. Rogers, deputy director, Office of Regional Operations, said today (March 25, 2010)  tried to outline how an FDA inspection tends to work, and what drives inspectors before, during and after an inspection.

As an aside, Rogers also said that the agency currently has about 1,800 total inspectors across its full portfolio, though food gets the bulk of the bodies. He also said there will be more foreign inspections this year, and that the number should continue to grow.

Inspections are based on risk, Rogers said. In other words, the riskier the potential drug, device or food item, the more likely they will be inspected.

Most inspections are unannounced, Rogers said. Before they go on-site, the inspector on inspection team will look at previous inspection reports and identify what corrective actions were promised during prior inspections. They also prepare inspection tool kits with sampling equipment, info to drive inspection based on guidance documents and the Investigation Operations Manual. They also carry a camera to document evidence.

They also conduct “for cause” inspections driven by consumer complaints or other outside activity.

Typically, the inspection begins with a discussion with management to explain the purpose of the inspection, and they try to learn about the corporate structure and any changes made since last inspection. They also ask about complaints, positive tests or returns. Answers to those questions help FDA inspectors focus their on-site efforts.

Next, they go to the physical manufacturing area. They try to observe and understand the on-site process. They ask about acceptance criteria and want specifics on failures, especially the reasons.

Inspectors also draw a diagram of the facility showing the manufacturing process from start to finish. They’re looking for problems in the system and looking to identify critical control points in the manufacturing process.

FDA inspectors then identify procedures in place and assess if company is actually following them. They also look for controls in place to mitigate any contaminated products.

They also look at training and cleaning programs. They also watch employees while they are actually making the product.

If they find evidence of an adulterated product, they collect evidence based on inspector observations and collect samples to prepare their case for possible legal action in court.

At conclusion of inspection, the FDA team meets again with management. They then inform the top company official what is in the official Form 483. That form documents observations during the inspection but does not include final recommendations. They also ask for the firms corrective actions planned or in place to get into compliance.

These corrective actions are taken into account as agency formulates official recommendations.

After the inspection at the firm, the inspector develops a report back at the home office. It includes evidence collected and what the firm has already agreed to do about any shortcomings.

In some cases firms can offer voluntary corrections. But sometimes the agency decides it needs enforcement action such as a warning letter, and can also impose civil and/or monetary penalties.

The webinar was extremely popular. In fact, it “sold out” so many who tried to join it could not get in to the live event. There will be a recording available on Monday March 29.

UPDATE: Slides are now available from this event here in PDF format.

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Filed Under: FDA Regulated, Food, Medical Devices, Michael Causey, Pharma/Biotech, Regulatory, Risk Management, Uncategorized, Warning Letters/Recalls Tagged With: , , , , , , , ,

Former FDA inspector Miles on What FDA Looks for During Inspections & the Importance of Strong CAPA Systems

December 1, 2009 By 1 Comment

Ken Miles, Former FDA Inspector

Ken Miles, Former FDA Inspector

Ken Miles, a 28 year veteran of the FDA, is today a widely-respected industry consultant to the medical device industry. He draws on his extensive experience to help firms effectively and efficiently comply with FDA requirements. Ken’s expertise includes evaluating Good Manufacture Practice (GMP) and Good Laboratory Practice (GLP) compliance, Quality System Regulations, and QSIT certification inspections (Management, Design, Process Controls, and CAPA).

In this multi-part series, we talked with Ken about FDA inspections, CAPA, quality systems, audits, training and more.

Q: When you were with the FDA, what did you look for during onsite inspections at medical device facilities?

A: What I primarily looked for was a robust quality management system that covered all of the key areas: CAPA, internal quality audit findings, training, MDRs and complaints, supplier quality, etc.   Supplier audits are also very important, and they should always tie back into CAPA and management review findings.

Q: You mention training as part of the overall quality management system –  what kind of problems did you see in that area?

A: The most common problem with training is that programs are often inadequate. Oftentimes procedures are either nonexistent or very poorly written. You need to have stringent management commitment and oversight, while also removing irresponsible people who can seriously damage the business. Procedures, management review and training are the primary areas that should generally be addressed through a CAPA program to make it work.

Q: Digging deeper, what were the CAPA-related issues you saw most often during inspections?

A: The one thing I saw often was that companies did not prioritize their CAPA items. You need to prioritize them using a risk-based approach. The highest priority ones should be put at the top of the list. Sounds like an obvious thing, but a lot of companies just throw all CAPA related issues into one bucket with no priority or even closure dates. If you don’t have some sort of prioritization system, you might become weighed down with too many assignments with no end in sight. Prioritize by low, medium and high priority, as well as severity of consequences. That would also imply that you have a target date, or closure date once you implement that program. A lot of companies don’t do that.

Q: You stress the importance of prioritizing and setting due dates for CAPA. Can you give us some examples of what you looked for during your inspections?

A: Medium and serious CAPA issues should be closed out within 30 or 90 days at the most. I’ve seen situations where CAPAs are still hanging out there after two or three years! And I’ve even some that have never closed or resolved! In certain situations, I’ve also seen CAPAs that don’t even have a closure date. Unfortunately, that’s typical of spreadsheet based CAPA systems.

In the next part, we will delve deeper into actual situations, and discuss some of the more egregious things that Ken Miles experienced as an FDA inspector.

Click here for more detailed information about CAPA.

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Filed Under: FDA Regulated, Quality Management, Regulatory, Tamar June Tagged With: , , , ,

The Most Common Drug and Device GMP 483 Items

October 5, 2009 By 6 Comments

fda-logoIn a recent FDA presentation Foster City, CA, Mark Roh, Regional Food and Drug Director outlined the most common cited 483 items for both pharma and med device companies:

The most common Drug GMP FDA-483 (observational) items:

  • Responsibilities and procedures of the Quality Control unit are not in writing
  • Written procedures are not followed
  • Control procedures not established
  • Inadequate specificatons
  • inadequate written procedures
  • Inadequate failure analysis

The most common Medical Device GMP FDA-483 (observational) items:

  • Deficiencies in complaint file system
  • Inadequate CAPA procedures
  • Lack of written MDR procedures
  • Corrective and preventive actions not documented
  • Inadequate process validation

This doesn’t mean you won’t be cited for anything not listed in the bullet items or nabbed for all of the above. These are the most common observations cited by FDA personnel during an inspection. So now you may want to go back and take a good hard look at your SOPs, quality management system, CAPA process, complaint handling/MDRs as well as your validation documentation. Obviously training your personnel in these procedures and processes is also key.

Of course, everyone’s goal is not to end up here…

Also, you may want to check out our previous blog entry “Don’t Ignore 483s…it’s in Your Best Interest to Respond in Writing“

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Filed Under: FDA Regulated, Medical Devices, Pharma/Biotech, Quality Management, Regulatory, Tamar June Tagged With: , , , , , ,

Royal Bank of Scotland uses CATSWeb OnDemand for Managing Quality and Compliance Activities

April 13, 2009 By Leave a Comment

rbslogoThe Royal Bank of Scotland (RBS Group) is one of the top 10 banking groups in the US and a principal supplier of corporate finance and debt capital markets services, with retail banking franchises stretching from New England to the Midwest.

In 2005, Juel McQueen, Assistant Vice President, Compliance, and her team in quality assurance needed a solution to track all corrective actions, periodic reviews and verification documents. Since resources for IT were already stretched, they decided to pursue a solution that was available as SaaS (Software as a service). After researching numerous vendors, Ms. McQueen and her team selected CATSWeb OnDemand with the blessing of their IT department because it suited their needs for security, functionality and versatility. CATSWeb is hosted at a SAS 70 Type II certified facility.

Prior to CATSWeb, the QA department was using Microsoft Word and Excel and routing files by email to solve their corrective actions and sign off on documents. Some of these attachments ended up being accidentally deleted or overlooked.  Now, instead of relying on file attachments in email, all users log into the CATSWeb system, view the tasks and documents assigned to them, and electronically sign off on them in a much more accurate and timely manner.

“AssurX helped me get started on the system with initial training, and now I do the necessary configuration changes myself,” said McQueen.

In addition to providing a centralized system for users, CATSWeb also generates executive reports for test results, findings and corrective actions.

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Filed Under: Quality Management, SaaS & Cloud Computing, Success Stories, Tamar June Tagged With: , , , , ,

FDA Importer Guidance for Medical Devices: What it Means to you Going Forward

March 17, 2009 By 2 Comments

intensive care unit monitorThe FDA has had many challenges and setbacks in the past few years. From budget cuts to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug and food recalls.

Off the record, current and former FDAers have told us that they know they’ve been understaffed and underfunded in recent years, and that their enforcement capabilities often weren’t up to the task.

Now with a new president and renewed focus on government regulation in Washington, it’s likely pressure from the White House and Capitol Hill will spur the agency to be more active this year and in the next several years, experts say.

In a new white paper from AssurX, you’ll learn why a FDA’s new Good Importer Practices draft guidance is putting the device industry on notice. The white paper explains that the FDA will:

  • Hold those at the top accountable for any import problems for their
    products,
  • Expect medical device manufacturers to be vigilant about quality, and;
  • Increase its emphasis on device firms’ catching and correcting mistakes and
  • complaints.

As this new guidance demonstrates, a revitalized FDA today demands that medical device manufacturers to build quality into their products from the very beginning, and to spot procedural problems very early in the product lifecycle.

At its heart, the FDA guidance wants device manufacturers to:

1) Establish procedures for developing corrective action plans, and for taking corrective and preventive actions if non-compliance with a U.S. requirement or a safety concern should arise.

2) Identify and investigate the root cause of non-compliance with U.S. requirements for products they import, or by foreign firms with which they do business.

3) Take steps to remediate and prevent harm from present and future shipments, and to ensure non-compliance and safety problems do not recur.

4) Work with the non-compliant firm to meet U.S. requirements, or stop conducting business with that firm.

“This is part of a broader effort, pushing responsibility for manufacturing on the manufacturer,” says Mark Mansour, an attorney with Bryan Cave LLP in D.C. While the FDA is saying it will inspect and enforce more, manufacturers are counted on as the “first line of defense,” he adds. “Device firms should take this very seriously,” Mansour said.

Request your copy of the FDA Importer Guidance for Medical Devices paper here.

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Filed Under: FDA Regulated, Featured, Medical Devices, Quality Management, Tamar June Tagged With: , , , ,