This webinar explains how auditors can investigate unexpected increases in bioburden as part of a bioburden failure analysis that will be used to implement containment, corrections and corrective actions.
Every medical device company with a controlled environment and sterilized products is required to monitor bioburden and to implement process controls to ensure that bioburden remains within the validated limits. Unfortunately, there are so many possible sources of bioburden it is easy to have a sudden increase (i.e., spike) in the bioburden of raw materials, finished devices or the controlled environment. Human error is usually blamed, but retraining people is not an effective corrective action. You need to design solutions that eliminate the need for human perfection. When a spike occurs, what do you do?
This webinar will help you pinpoint the actual cause of your bioburden problems. Identifying the actual cause of quality issues is critical to developing effective corrective actions. If you do not narrow the potential causes down to the actual cause or causes, then you will waste time and money implementing solutions you didn’t need. If miss the actual cause of exceeding your validated bioburden limits, then your corrective actions will not be effective and you will need to re-open your CAPA or initiate a new CAPA. You may also be forced to recall nonconforming product.
In this presentation our speaker explains how to use the process approach to auditing in order to identify the root cause for excursions above established bioburden limits for: 1) raw materials, 2) finished devices, and 3) controlled environments. It’s easy to think of ways your process controls could have failed, but you will save time and money if you can identify how your process controls actually failed.
Join us for this webinar as our speaker teaches you how to use your auditing skils to investigate the cause of exceeding validated bioburden limits.
This webinar covers:
- Important environmental monitoring data to collect and analyze
- Most common reasons for exceeding validated bioburden limits
- Containment and Corrections
- Corrective Actions & Preventive Actions
- Training & Quality Objectives
Who should watch?
- Internal Auditors and Supplier Auditors
- Anyone Responsible for Controlled Environments
- Anyone Responsible for Investigation of Bioburden Failure Analysis
Please Note: Purchase of the webinar includes the Native PowerPoint slide deck and the recording of the webinar. You will have the ability to share this content with anyone in your company—as many times as they wish.
This webinar recording is only $129 (AND INCLUDES – SLIDE POWERPOINT PRESENTATION):
This webinar explains the process for auditing the environmental monitoring process and controlled environments. The recording will be sent in a separate email and this product includes a copy of the native PowerPoint slide deck.
Exam and Training Certificate available for $49.00:
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.
VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:
About Your Instructor
Robert 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 802.281.4381 or email.