Medical Devices
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Auditing Computer Systems for FDA and International Compliance
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic... -
Auditing Computer Systems for FDA and International Compliance
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic... -
Auditing Laboratory Data Systems
The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with... -
Auditing Laboratory Data Systems
The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with... -
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Avoid Reporting Cybersecurity Updates and Patches to the FDA
Is a cybersecurity patch or update a reportable event under the Reports of Corrections and Removals regulation? (21 CFR Part 806) The FDA issued a guidance document recently entitled, “Postmarket Management of Cybersecurity in Medical Devices.” It explains that... -
Avoid the Most Common Sources of ISO 9001:2015 Nonconformances with the Process Approach
Penny Ouellette’s “ISO 9001:2015 Implementation: The Good, the Bad and the Trending” (Quality, November 8 2018) provides a valuable list of the most frequent clauses that are cited in ISO 9001:2015 findings. These are: Clause 4.4.1, Quality management system... -
Avoiding 483’s Throughout your Organization – Strategies, Risk and Mitigating Approaches
Certainly the most simplistic solution to achieving compliance excellence and 483 avoidances is “to do the right things right!” But what does this really mean? I have distilled the “doing the right things right” solution into 7 separate individual... -
Basic Requirements for IQ, OQ and PQ Quality Protocols
Current regulatory requirements state the need to prove equipment, systems and utilities are verified to perform their desired functions. This verification comes in the form of qualification protocols that verify proper installation, operation over its entire range, and acceptable... -
Best Practices For A Compliant, Lean Supplier Management Program
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meet all... -
Best Practices for Having Successful Performance Discussions
How we talk about performance – how successful we are in doing this – is critical to the team relationships we forge and the effectiveness of team performance. Part of talking about performance is knowing how to have an... -
Best Practices in Preparation for an FDA Computer System Audit
The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and... -
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Best Practices in Providing Coaching and Feedback to Team Members
Why Should You Attend Most times, we conform and accomplish satisfactory work because we are forced to by management, our peers, and the organization. Superior work on the other hand is only achievable when we want to achieve... -
Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo
This seminar presentation will provide great opportunities to get familiar with the “Best Practices” on how to obtain FDA’s constructive feedback on regulatory questions prior to preparing for and submitting a 510(k) and de novo request. In particular, the... -
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
The seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and... -
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
The seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and... -
Big Data – Tools and Trends for Improving your Quality System
Data, data everywhere. In today’s world, we have access to tremendous amounts of data. Yet, it is difficult to translate this data into useful information. Translating data into meaningful information is a capability that can be a competitive strength...
