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Online Conference Biochimy : Verification vs Validation-Product, Equipment and QMS Software
Overview: You will learn What do the U.S. FDA and EU Expect for Verification and Validation, Actions and documentation to meet U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements...
Concerned sectors: Biochimy -Biotechnology -
Online Conference Biotechnology : When Conducting cGMP Regulatory Inspections 2018
Overview: This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you wi...
Concerned sectors: Biotechnology -Public Health -
Online Conference Biotechnology : Revolutionary Change in FDA Software Regulation
Overview: It is not about giving an OK to products, it is about trusting the manufacturer to do the right thing. Overall, your regulatory approach to software regulation needs to ease up and reap the...
Concerned sectors: Biotechnology -
Conference / Seminar Biotechnology : What you Need to Know to Prepare FDA Inspection
Overview: Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This w...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : What are the Tools required for Human Error Reduction
Overview: This course offers practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : FDA During New (Drug) Development 2018
Overview:  Why is it important to engage with the FDA? To discuss your development plan to support NDA or BLA regulatory submission To identify and mitigate potential issues early To identi...
Concerned sectors: Biotechnology -
Conference / Seminar Medical and Hospital Management : Moving From An Operational Manager to A Strategic Leader | Washington Seminar
Course "Moving From An Operational Manager to A Strategic Leader" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full c...
Online Conference Biotechnology : Best Practices for Foundational (Employee) Success 2018
Overview: FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in light of its evaluation of how to best ac...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : Compliance for Electronic Records and Signatures (21 CFR Part 11)
Overview: Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based valida...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : Highlights of FDA GLP Regulations and the (Roles) and Responsibilities
Overview:  This 3 hour GLP virtual seminar will discuss various GLP regulations (FDA/OECD GLP's) along with highlighting roles and responsibilities of management and key personnel involved i...
Concerned sectors: Biomedical -Biotechnology -
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