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67 results of "Manufacturing x" and "Quality Management System x"
Live Webinar

Project Management for FDA-Regulated Companies

This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time. It ...

Live Webinar

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation This highly interactive training uses life examples and explores proven techniques for reducing costs, usually by two-thirds, as ...

Live Webinar

21 CFR Part 11 (Electronic Records and Signatures) Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...

Live Webinar

CAPA: Corrective and Preventative Actions and Non-Conformances

Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the problem occurred in the first place. If you only fix the symptoms – what you see on the surface – the problem will almost certainly happen again, w ...

Live Webinar

From Risk Control To Risk Management

This can lead to following regulation to the detriment of managerial principles.: the former aims at keeping averting the most dramatic impacts, whilst the latter helps towards optimizing the risk profile of the enterprise at all times. Such confusion inevitab ...

Live Webinar

Is it Microbiological Method Verification or Validation, or Just Semantics?

This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation in food/water microbiology. Quantitative and Qualitative methods have different ...

Live Webinar

Computer System Validation (CSV) vs. Computer Software Assurance (CSA) as an Approach to Meeting FDA Compliance

As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting regulatory compliance requi ...

On-Demand Webinar

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...

Recorded Webinar

EPCRA TRI Form "R" Reporting

This training program will help attendees understand the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxic Release Inventory (TRI) Form R reporting requirements. It will also elucidate what the EPCRA TRI Form R is, when they are required to be f ...

On-Demand Webinar

EPCRA TRI Form "R" Reporting

Under the Environmental Protection Agency (EPA) regulations, the Emergency Planning and Community Right-to-Know Act (EPCRA), Facilities are required to report the Toxic Release Inventory (TRI) Form R Reports by July 1st of each year. The TRI Form R Reporting i ...

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Validity : 21st Sep'21 to 01st Oct'21