Search Results for: 13485

4 Ways to Make the Best Use of Medical Device Remote Audits

2 Comments / ISO Auditing / By / , , , , , , , ,

This blog identifies how to use medical device remote audits effectively, save time and resources, and when you should not conduct audits remotely.remote audits blog 4 Ways to Make the Best Use of Medical Device Remote AuditsMost audits ISO 13485 are performed onsite at the location where the processes are being performed, and are the most effective approach to internal and supplier audits. But conducting an audit from your desk makes more efficient use of your time as an auditor. A large percentage of audits are conducted from conference rooms where the auditor spends an excessive amount of time reviewing documents and records, or waiting for documents and records to be delivered. 

In 2006, the first edition of the ISO 17021 standard for certification of quality systems by certification bodies was released. ISO 17021 requires that initial certification audits be conducted in two stages. Stage 1 has several requirements, but the first element of Stage 1 is reviewing quality system documentation. In most cases, Stage 1 and Stage 2 audits are conducted onsite. Still, if the auditee is located in a remote location (such as New Zealand), Stage 1 audits will sometimes be conducted via conference call. 

Prior to ISO 17021, a review of quality system documentation was the only task performed before the initial certification audit, and the documentation review was typically conducted remotely as a “desktop” audit. Desktop audits have been used for decades as a way of auditing quality system documentation without traveling. However, desktop audits can be much more than a review of quality system documentation. You can interview auditees on the phone, review records, even ask auditees to demonstrate activities in real-time using a web camera.

Documentation can also consist of much more than text. Raw data, statistical analysis, and photos can be used to communicate additional information. The more multimedia content provided to auditors remotely, the closer a remote audit becomes to auditing on site. The same requirements as certification bodies do not bound internal auditors and supplier auditors, and audits may be conducted onsite or remotely. The most recent version of ISO 19011 (2011), includes a comparison table for onsite and remote auditing in Annex B.

Medical Device Remote Supplier Audits

The use of remote audits to qualify suppliers is not recommended for four reasons:

  1. onsite visits facilitate the building of supplier-customer relationships
  2. touring facilities and watching a demonstration of processes improves understanding of a supplier’s processes better than reading documents and records can
  3. Cleanliness and capabilities of suppliers are best evaluated onsite, where camera angles can be used to crop out important details
  4. sometimes suppliers misrepresent their capabilities by showing photographs on their website of other companies.

After you have qualified a supplier, however, you may not need to audit them onsite regularly. If a supplier’s performance is good and risks associated with nonconforming components supplied are minimal, then you have a justification for conducting a remote audit. However, if a supplier’s performance is poor, you may want to use a remote supplier audit as a precursor to an onsite supplier audit to investigate the reasons for nonconforming components (i.e., a “for cause” audit). Regardless of the situation, the amount of time spent in your supplier’s conference room should always be by reviewing documents and records remotely. This will reduce the amount of time required at each supplier, and enables you to audit two suppliers during the same trip.

Medical Device Remote Internal Audits

It might not occur to you that there would be any need for remote internal audits. However, not all internal audits are performed by a person working at your location. Larger companies have multiple sites, and many of the internal audits are performed by auditors from corporate headquarters and other locations. In the case of internal audits performed by auditors from other locations, travel time can be minimized by performing part or all of the internal audits remotely. This approach can also work for consultants hired to conduct internal audits. There is no need to spend money on the cost of travel for a consultant if the consultant is only going to be auditing documents and records. The following are great examples of processes that can be audited remotely:

  1. CAPA
  2. Management Review
  3. Internal Auditing
  4. Supplier Controls
  5. Complaint Handling
  6. Adverse Event Reporting

Medical Device Remote Re-audits

21 CFR 820.22 indicates that re-audits may be required where corrective actions have been taken to verify the effectiveness of the actions taken: “Corrective action(s), including a re-audit of deficient matters, shall be taken when necessary.” However, if nonconformities identified during an audit are categorized as “high-risk,” it may be essential to conduct a verification of corrective action effectiveness as soon as possible.

Sometimes, effectiveness can be determined by reviewing quantitative metrics. Still, if a re-audit is needed, then a remote re-audit may allow the auditor to verify the effectiveness of corrective actions without the necessity of being onsite. If verification of corrective action effectiveness can be performed by reviewing documents and records, a remote re-audit is appropriate. Other corrective actions, especially those involving production and process controls, typically require onsite verification.

Remote Audit Team Members

Most medical device companies have a limited number of qualified auditors, and auditing is almost always a secondary job duty. However, audits often require specific technical knowledge that only one or two auditors may possess. Therefore, it may be extremely difficult to schedule a team audit when all the required auditors and auditees are available. There is another option to postponing your audit. You might consider having some of your auditing team members audit remotely from their desks, while the rest of the team conducts an onsite audit. For example, most lead auditors can conduct a process audit of incoming inspection, storage, and shipping. However, auditing surface mount assembly lines for the fabrication of printed circuit boards requires more technical knowledge of this type of process. Technical expertise is also needed to audit sterilization or CNC machining.

By working together, onsite audit team members can take directions from a technical subject matter expert working remotely and gather information needed to audit any process properly. This approach minimizes time requirements for subject matter experts, and remote audits by team members reduce the cost of travel.

If you are interested in learning more about Turtle Diagrams and the process approach to auditing, please register for our webinar on the process approach to auditing. If you are interested in learning more about how you can use remote audits to save time and money, please contact us. We can help you identify immediate opportunities.

4 Ways to Make the Best Use of Medical Device Remote Audits Read More »

7 Steps to Respond to an FDA 483 Inspection Observation Webinar

Leave a Comment / By

Rob Packard of Medical Device Academy provides 7 proven steps to effectively respond to an FDA 483. Included are examples, recommendations and tips; for implementing the 7 steps including:

  1. Respond within 15 business days
  2. Use your CAPA form
  3. How to document a root cause investigation
  4. Don’t forget correction and containment
  5. Corrective action plans
  6. Show you have already taken action
  7. Follow up before the FDA

Other topics reviewed include: 

  • 8 D Process-“8 Disciplines” to be utilized as a model for an effective CAPA process
  • Recalls
  • Documentation
  • Effectiveness checks (examples)
  • Trend analysis

7 steps 7 Steps to Respond to an FDA 483 Inspection Observation Webinar

This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):

7 steps1 7 Steps to Respond to an FDA 483 Inspection Observation Webinar
7 Steps to Respond to an FDA 483 Inspection Observation Webinar
Includes PowerPoint Slides
Price: $129.00

Exam and Training Certificate available for $49.00:

exam10 150x150 7 Steps to Respond to an FDA 483 Inspection Observation Webinar
EXAM - 7 Steps to Respond to a 483 Inspection Observation
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
Price: $49.00
Your cart is empty

VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:

SOPS 7 Steps to Respond to an FDA 483 Inspection Observation Webinar

About Your Instructor

Medical Device Academy Robert Packard 7 Steps to Respond to an FDA 483 Inspection Observation WebinarRobert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

7 Steps to Respond to an FDA 483 Inspection Observation Webinar Read More »

Suggestion Portal & 404 Page

Leave a Comment / By

Welcome to the Medical Device Academy’s virtual suggestion portal and our re-directed webpage instead of seeing a boring 404 error page.Suggestions line art Suggestion Portal & 404 Page

Please submit your ideas to our suggestion portal

We need and want your suggestions. Please submit your suggestions for our YouTube channel (including the Friday Live Streaming videos), blogs, webinars, or the new LearnDash beta testing website. We use your suggestions to help us create new content that you actually want and need. It’s also free consulting for you.

Do you have any suggestions for better methods of content delivery?

Any suggestions you have for better methods of content delivery would be greatly appreciated. We use AWeber as our email subscription service, but spam filters make it challenging. We don’t spam, but you can always adjust the subscription settings at the bottom of AWeber emails.

If you are afraid of the suggestion portal…

An alternative to using this virtual suggestion portal is to visit our calendar page to schedule a 30-minute meeting with Rob Packard. The calendar page is linked directly with Rob’s Google Calendar, and you will be able to schedule a meeting with him that is mutually convenient. You can also visit the contact us page to find his email and phone number.

404 Errors

If the webpage you were trying to reach is not available, we apologize for the glitch in our website. Please tell us what you were looking for and how you got here by filling in the suggestion portal form above. We will reply directly to your message, and we will implement our own correction and/or corrective action to prevent this from recurring.

If we did not address your complaint…

If you feel we are not adequately addressing your complaint, maybe you need to be more creative in the wording of your complaint. We recommend the following video as instructional material on the proper method for complaining about our inadequate website.

Suggestion Portal & 404 Page Read More »

FDA Medical Device Recalls, Labeling and 21 CFR 820.120

Leave a Comment / By

Many companies struggle with deciphering FDA medical device recall regulations and misinterpret 21 CFR 806 (http://bit.ly/21CFR806-Recall). Fortunately, FDA 483 inspection observations can be easily avoided by doing two things. First, personnel responsible for corrections and removals need proper training—not just “read and understand.” Second, your forms and procedures need to comply fully with 21 CFR 806.

This 70+ minute information-packed webinar recording reviews critical considerations in conducting an effective 8-step recall in compliance with 21 CFR 806. One of the most common recalls is related to labeling errors. The impact of labeling errors can be significant to a patient. How to prevent labeling mixups is reviewed. You will also learn the 7 steps to conducting an effective process audit of both labeling and a recall.  

FDA’s involvement in recalls-what actions do they take in performing an effectiveness check?  What are the 5 most common mistakes related to compliance with 21 CFR 806? What if you make a mistake-what are the regulatory consequences?  These questions and more are answered in this webinar. 

You also receive information links for recalls regulations, recalls database, guidance documents and FDA recall coordinators.  

FDA Recall 01 FDA Medical Device Recalls, Labeling and 21 CFR 820.120

This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):

FDA Recall 011 FDA Medical Device Recalls, Labeling and 21 CFR 820.120
FDA Medical Device Recalls, Labeling and 21 CFR 820.120
Price: $129.00

Exam and Training Certificate available for $49.00:

exam10 150x150 FDA Medical Device Recalls, Labeling and 21 CFR 820.120
EXAM - 7 Steps to Respond to a 483 Inspection Observation
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
Price: $49.00
Your cart is empty

VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:

SOPS FDA Medical Device Recalls, Labeling and 21 CFR 820.120

About Your Instructor

Medical Device Academy Robert Packard FDA Medical Device Recalls, Labeling and 21 CFR 820.120Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

FDA Medical Device Recalls, Labeling and 21 CFR 820.120 Read More »

5 Criteria for a Certified Internal Auditor Program

1 Comment / ISO Auditing / By / , , , , ,

5 criteria 5 Criteria for a Certified Internal Auditor ProgramThis article identifies five criteria for a certified internal auditor program of medical device lead auditors for ISO 13485 quality systems auditing and supplier auditing.  Five criteria are important to a certified internal auditor program:

  1. formal training by a qualified trainer
  2. an exam to demonstrate the effectiveness of training
  3. practical experience
  4. observation of actual audits by an experienced lead auditor
  5. documentation

Internal auditors do not need a certificate from a third-party (i.e., someone other than your company or your customers), and training programs do not need to be accredited. Your company can save money and develop an in-house certification program. The only reason why third-party certification and accreditation are needed is 1) if your internal auditor procedure requires it, or 2) if you are training to become a third-party auditor working for a certification body or registrar. Therefore, I don’t recommend writing a procedure that requires a certificate from a third party or an accredited program. Write your internal auditor training requirements to allow flexibility, but ensure you include each of the five elements listed above.

1. Formal training by a qualified trainer

Formal training is planned and has a documented curriculum. The curriculum can consist of one long course over several days, or you can limit the duration of each class to an hour over several months, and you can develop a schedule to fit individual needs. Training should be customized to a certain extent for each internal auditor, but most programs have at least one primary lead auditor course that everyone must complete. A qualified trainer must also deliver formal training.

2. An exam to demonstrate the effectiveness of training

I have written about the use of exams to document training effectiveness. You can use a combination of multiple-choice questions, fill-in-the-blank, short answer, and essay questions for an exam. However, for demonstrating the effectiveness of auditor training, there is one method of evaluation that is superior to all others–writing nonconformities. If you provide a hypothetical scenario to an auditor, the auditor should be able to write a complete nonconformity. This exercise tests the auditor’s ability to identify the applicable regulatory requirements, assess conformity, grade nonconformities, and select the appropriate wording of the nonconformity and associated objective evidence. The only downsides to writing nonconformities are: 1) they are harder for instructors to grade, and 2) the grading is subjective.

3. Practical experience

The most common way to document the previous experience of internal auditors is to include a copy of the person’s resume in their training record. However, I recommend using a tracking log for all audits to identify which auditors conducted which audit. Ideally, you want to use an electronic database that allows you to search the database using the name of the auditor as a search field. Your database should also indicate which role the auditor was fulfilling: 1) lead auditor, 2) team member, 3) trainee, or 4) observer. Sometimes, the person may have more than one role (e.g., team member and trainee or lead auditor and observer).

4. Observation of actual audits by an experienced lead auditor

It doesn’t matter if training is remote and recorded or live and in-person, but remote and recorded training needs to balanced with an observation of actual audits by an experienced medical device quality system auditor. “Observation” needs to be defined, but I recommend using a controlled form to document observations. Attaching a completed observation form to a copy of auditing notes and a copy of the audit report creates a complete record to demonstrate observation of each audit by a trainee. Just don’t make your controlled form overly burdensome. A single page is fine–as long as it consists of more than yes/no checkboxes. “Experienced” also needs to be defined, but I recommend the following combination of qualitative and quantitative experience. First, an experienced lead auditor must have documented formal training, but formal training does not need to be third-party training. Second, an experienced lead auditor should have completed at least 100 audits. One hundred is an arbitrary number, but that number represents more than 1,000 hours of audit preparation, auditing, and report writing. Anything less than 1,000 hours is inadequate to be qualified to begin training others.

5. Documentation

Documentation must include all of the above elements. You need to document the training plan for each internal auditor, and it must meet minimum training requirements–which should be documented in your internal auditing procedure. Your documentation should include minimum criteria for qualification of a trainer–often a resume, and adding the person to your approved supplier list is sufficient. You should document the results of any formal quizzes and exams for training effectiveness. Auditing experience for each person should be documented. Specifically, you should have a form listing a description of the scope and dates for each audit during the certification process. Observations of auditors need to be documented, and any corrections or recommendations for improvement should include documented follow-up. If an auditor already has extensive experience before joining your company, your procedures should allow for a written justification, instead of repeating the training. If your company uses a software tool to manage training, I recommend creating a separate training group for internal auditors, rather than incorporating internal auditing into another job description and/or training curriculum.

What Really Matters

What matters is whether your internal auditor training is effective and internal auditors are competent. Certificates make pretty training records to post on the wall of your cubicle. Competent internal auditors identify quality issues before you receive an FDA 483, or a nonconformity from your certification body. Competent auditors also add value by identifying ways to make processes more efficient and opportunities to save money. If you are looking for a qualified trainer to provide formal training, in a public venue or in-house, please visit the following webpage: http://bit.ly/Lead-Auditor-Course.

5 Criteria for a Certified Internal Auditor Program Read More »

Learn how to audit using the process approach webinar

Leave a Comment / By

This process approach webinar will teach you how to audit your quality system to ISO 13485:2016 or any other quality system standard.

Your cart is empty
Turtle Diagram for Process Approach Webinar Learn how to audit using the process approach webinar

When is the process approach webinar?

The process approach webinar was originally recorded on September 18, 2015. We are recording an updated webinar on June 23, 2020, @ 2:00 pm EDT. If you already purchased the webinar, you will receive an automated email inviting you to participate in the webinar. If this is a new purchase of the webinar, you will receive a link for downloading the old webinar and an invitation to participate in the new live webinar. Everyone that purchases the webinar will receive a link to download the recording if they are unable to attend the live webinar.

Changes to the process approach to auditing since September 18, 2015

When the previous version of this webinar was recorded, the final draft of the ISO 13485:2016 standard had not yet been released. In addition, the current version of the guidelines for quality system auditing was updated in 2018 (ISO 19011:2018). There were no changes to the requirements for internal quality audits in the 2016 standard, but the clause numbering shifted from Clause 8.2.2 to 8.2.4. This shift was necessary to accommodate the addition of Clause 8.2.2 for complaint handling and Clause 8.2.3 for reporting to regulatory authorities. 

The changes to ISO 19011 were more significant. ISO 19011:2018 includes the addition of the risk-based approach to auditing as one of the seven principles of auditing. Three sections of the guidance were also expanded: 1) audit program management, 2) how to conduct an audit, and 3) generic competency requirements for auditors. There was also an expansion of the concept of virtual audits (i.e. remote auditing) in Annex A of the guidance. The expansion of Annex A also included guidance on other new auditing concepts: organizational context, leadership, commitment, compliance, and supply chain. 

Description of the process approach webinar

How to audit using the process approach webinar reviews how to effectively utilize the process approach to auditing. It also includes bonus materials. Internal auditors receive audit training and are generally told to use the process approach. Unfortunately, most auditors still use checklists organized by procedure or clauses of the ISO standard. However, checklists ignore process inputs and outputs and instead ask auditors to verify that a specific requirement of a procedure or the ISO standard has been met. Even though most auditors record objective evidence of the records sampled and the person interviewed, the checklist approach results in a superficial audit. Accredited lead auditor classes are required to teach the use of process turtle diagrams instead. Process turtle diagrams are a simple, seven-part tool used to take notes when you are auditing. All you need is a pen, a blank piece of paper, and training on how to use the process approach.  

How to audit using the process approach webinar covers:

  • What is the process approach to auditing?
  • Why is the process approach more efficient than audit checklists?
  • What is a turtle diagram?
  • In what order should you ask audit questions?
  • Who should you assign to each process and why?
  • How you can add more value during audits?

WEBINAR OVERVIEW VIDEO:

Includes bonus material to keep in your educational toolbox

toolbox Learn how to audit using the process approach webinar

  1. Examples of 3 Turtle Diagrams Completed in Preparation for an Audit (PPT & Excel)
  2. Example Audit Notes Form for Design Process
  3. Example Process Audit Traceability Matrix
  4. Examples of 3 Audit Agendas Used in Presentation
  5. PLUS  – Native PowerPoint Presentation included with this recording

Who should attend the process approach webinar?

  • Supplier quality
  • Quality assurance
  • Auditors
  • Lead auditors
  • Audit program managers
  • Senior management

All this for only $129.00

AKA Turtle Diagram Thumbnail Learn how to audit using the process approach webinar
How to audit using the process approach webinar
How to audit using the process approach webinar is being updated for 2020. The webinar covers the following topics: What is the process approach to auditing? Why is the process approach more efficient than audit checklists? What is a turtle diagram? In what order should you ask audit questions? Who should you assign to each process and why? How you can add more value during audits?
Price: $129.00

exam7 150x150 Learn how to audit using the process approach webinar
EXAM - How to use the process approach (a.k.a. – Turtle Diagrams)
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
Price: $49.00

VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:

SOPS Learn how to audit using the process approach webinar

About Your Instructor

Home page video cropped 150x150 Learn how to audit using the process approach webinarRobert Packard is a regulatory consultant with 30 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone at 802.258.1881 or by email. You can also follow him on Google+, LinkedIn, YouTube, or Twitter.

Learn how to audit using the process approach webinar Read More »

Medical Devices Compliance

Leave a Comment / By

Medical Device Academy offers medical devices compliance solution-based consulting services, including:COMPLIANCE SHADOW Medical Devices Compliance

  • Quality Systems audits
  • Compliance remediation
  • Mock FDA inspections
  • ISO 13485 certification
  • Risk management
  • Supplier quality management
  • Management review

[divider style=”hr-dotted”]

Below are some quotes from Rob Packard, author, from our blog archive

Auditing – “During the audit, you should always make the guide(s) and process owner(s) aware of any potential nonconformities as you find them. This is their opportunity to clarify the objective evidence for you and to explain why there is not a nonconformity.” –An Auditor’s Best Practices in Issuing a Major Nonconformity

FDA Inspections – “5. Shut it down – Not running a production line that has problems is a favorite strategy for hiding problems. However, the FDA and auditors will simply be forced to spend more time sampling and reviewing records of the problematic production line.”– 10 Inspection Strategies That DON’T Work

Management Review – “Every Management Review should include an action item scheduling the next Management Review. The timing of the next Management Review should reflect changes planned for the quality system and improvements needed to maintain effectiveness.” – How to Improve Your Medical Device Management Review Procedure

Risk Management – “In order to comply with the EN ISO 14971:2012 version of the risk management standard, you will need to implement risk controls for all risks, regardless of acceptability. However, you will also need to perform a risk/benefit analysis.”   – 7 Deviations within EN ISO 14971: 2012: Risk Evaluation Process

ISO 13485 Certification – “1. Select a certification body and schedule your certification audits (i.e., – Stage 1 and Stage 2). If you want to place devices on the market in the EU, Japan or Canada, make sure your certification body meets the specific regulatory requirements for that market.” –12 Important Tasks for Implementing ISO 13485

Supplier Quality Management – “Finally, my favorite criterion is size. I prefer a supplier that is approximately the same size as my company. If we are the same size, then problems should be equally important for both of us. If my company is bigger, we might tend to bully the supplier and the supplier might have difficulty growing with us. If my company is smaller, our problems might not receive the attention they deserve.” – Supplier Qualification Selection Criteria 

[divider style=”hr-dotted”]

Don’t forget about our Expert Blogs, Free Downloads, Webinars and Consulting Services

Medical Devices Compliance Read More »

Medical Devices Training

Leave a Comment / By

EDUCATION Medical Devices Training“Tell me and I forget. Teach me and I remember. Involve me and I learn.”  – Benjamin Franklin

Medical Device Academy offers solution-based medical devices training in a number of media platforms, including;

  • Webinars
  • Public and private in-house training courses
  • Blogs
  • Videos
  • SOP & Gap analysis templates
  • Whitepapers

[divider style=”hr-dotted”]

Medical Device Training Webinars

From complaint handling and European medical device regulations to management review, Medical Device Academy offers a number of complimentary and for purchase training webinars that provide solution-based information on critical regulatory topics. CLICK HERE

Medical Device Public Training Courses

Lead Auditor Training with Emphasis on FDA Inspection Readiness and 21 CFR 820 – Medical Device Academy’s lead auditor course is only 1.5 days long and our co-instructor is a former FDA investigator. In addition to meeting the requirements for ISO 13485 internal auditor training, the course emphasizes FDA inspection readiness and 21 CFR 820 requirements.

Conducting Effective Supplier Audits Training Courses – Rob Packard, President of Medical Device Academy, Inc., has conducted hundreds of supplier audits. Most supplier audits, however, are one-day audits that add little value and look at the same predictable elements every time. Rob has condensed the basics of supplier quality management down to a half-day (3+ hours) training course that includes his personal experience and practical supplier quality management advice that will save your company money

Blog Archive

Medical Device Blog Archive – From managing FDA inspections to obtaining ISO 13485 certification, our 120+ blog archive serves as an invaluable information resource for medical device quality professionals.

Videos

Medical Device Academy Videos – Medical Device Academy offers two complimentary videos, Best Practices in Medical Device Auditing and How Medical Device Academy Trains Client 

Downloads

FREE Downloads – Medical Device Academy provides a number of complimentary medical device quality information downloads including, whitepapers, gap analysis document, templates, SOPs, checklists and more.

[divider style=”hr-dotted”]

Don’t forget about our Expert Blogs, Free Downloads, Webinars and Consulting Services

web design training Medical Devices Training

Medical Devices Training Read More »

Complaint Handling and Vigilance Reporting Webinar

Leave a Comment / By

Complaint Handling and Medical Device Reporting are two of the FDA’s most frequently issued 483s and Warning Letters. ISO auditors and FDA inspectors alike review complaint records during every visit. In this webinar you will learn:

  • Deadlines for Complaint Investigations and Reporting
  • What to do when defective product is not returned
  • Benefits of automated software solutions
  • How to audit your complaint handling process
  • Differences between US, European & Canadian requirements

Exam and Training Certificate available for $49.00:

exam8 150x150 Complaint Handling and Vigilance Reporting Webinar
EXAM - Complaint Handling and Vigilance Reporting
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
Price: $49.00
Your cart is empty

Pareto Chart FY2013 483s Complaint Handling and Vigilance Reporting Webinar

This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):

Pareto Chart FY2013 483s1 Complaint Handling and Vigilance Reporting Webinar
Complaint Handling and Vigilance Reporting Webinar
Complaint Handling and Medical Device Reporting are two of the FDA’s most frequently issued 483s and Warning Letters.
Price: $129.00

VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:

SOPS Complaint Handling and Vigilance Reporting Webinar

About Your Instructor

Medical Device Academy Robert Packard Complaint Handling and Vigilance Reporting WebinarRobert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

Complaint Handling and Vigilance Reporting Webinar Read More »

Medical Device Regulation: FDA Pilot Programs for Global Harmonization

3 Comments / FDA / By / , ,

international harmonization Medical Device Regulation: FDA Pilot Programs for Global HarmonizationThis blog provides an overview of global harmonization efforts by the FDA that were implemented for medical device regulation.

Harmonization of international regulatory requirements for medical devices began in 1992 with the founding of the Global Harmonization Task Force (GHTF). There were five founding regulatory bodies: 1) US FDA, 2) Health Canada, 3) European Commission, 4) Therapeutics Goods Administration of Australia, and 5) Ministry of Health, Labour and Welfare in Japan. The organization created many guidance documents for the medical device industry, and members of the GHTF organization also participated in the development of ISO 13485 that was released in 1996. GHTF was disbanded in late 2012, and it has been replaced by the International Medical Device Regulators Forum (IMDRF), and IMDRF maintains the documentation created by GHTF.

In 1996, when ISO 13485 was released, Health Canada made certification to ISO 13485 mandatory for all medical device manufacturers that wanted to distribute in Canada. Health Canada’s requirement for ISO 13485 certification resulted in the widespread adoption of ISO 13485 certification throughout the world. At the same time, the US FDA chose to publish its Quality System Regulations. The QSR is very similar to ISO 13485, but there are minor differences beyond the obvious reorganization of the requirements.

FDA Modernization Act of 1997

Under the FDA Modernization Act of 1997, the FDA implemented a 3rd party review program for 510(k) reviews and inspections. This program involves “Accredited Persons” (AP) that have been trained by the FDA and work for a third-party consulting firm, registrar, or Notified Body. The FDA expanded the pilot program for third-party 510(k) reviews to include most 510(K) devices. Unfortunately, even though there was great interest from third-parties to participate in the program, there was little interest from manufacturers. After more than a decade, only the following seven third-party organizations have managed to get an Accredited Person (AP) to complete the qualification process so that they can perform inspections independently:

  1. BSI
  2. LNE/G-MED
  3. CMS/ITRI
  4. Orion Registrar
  5. SGS
  6. TUV SUD
  7. TUV Rheinland

The FDA continues to experiment with different approaches to international harmonization. In 2003, Health Canada (HC) signed a memorandum of understanding between Health Canada (HC) and the U.S. In 2006, the FDA launched the pilot, Multi-purpose Audit Program (pMAP). Third-party auditors performed ten combined audits. The conclusions and recommendations resulting from the pMAP were posted on the FDA website in 2010. One of the recommendations was to develop a guidance document for the format and content of regulatory reports. Therefore, in 2011, GD211 was released by HC, and several videos were posted on the FDA website by HC and the US FDA CDRH Learn webpage for training.

Once the 14 recognized registrars had managed to train their CMDCAS auditors on the GD211 report format, the FDA announced the Voluntary Audit Report Submission Pilot Program. For eligible companies, they may submit a regulatory report in the GD211 format, and the FDA will remove the manufacturer from the routine workload for FDA inspections. A few companies have taken advantage of this and successfully avoided a routine inspection for 12 months.

FDA’s New Pilot Program

Recently, the FDA announced a new Voluntary Compliance Improvement Program Pilot. This new program is a small pilot that will allow 3-5 manufacturers to select a third party (to be approved by the FDA) to help them identify areas for compliance improvement and initiate corrective actions. Identification of areas for improvement would presumably be determined during a mock-FDA inspection performed by the third party, but this is not explained in the FDA announcement. This program is available by invitation only, but it appears to be a significant departure from the AP program and voluntary submission of GD211 audit reports.

IMDRF is finally starting to have an impact on the harmonization of medical device inspections. In January 2014, the FDA began accepting inspection reports from the Medical Device Single-Audit Program Pilot (MDSAP) as a substitute for routine agency reports. Kim Trautman at the FDA is the IMDRF representative chairing the program, and her presentation announcing the program can be downloaded. This program should be extremely popular with manufacturers because the MDSAP reports can also be used to meet requirements for inspections by Japan’s MHLW and Brazil’s ANVISA. ANVISA has a massive backlog of inspections due to a strike by government workers, and many companies were forced to file a lawsuit against ANVISA to accelerate the inspection prioritization. The challenge with the MDSAP will be to train and qualify third parties to conduct the audits correctly.

Medical Device Regulation: FDA Pilot Programs for Global Harmonization Read More »

Scroll to Top