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Latest Master Validation Plan - The Unwritten Requirements

Réf: 29651 Mardi 18 Juin 2019 - En ligne

Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.   Why should you Attend: Verification and validation requirements have ...

ISO/IEC 17025:2017 Section 7 - Process Requirements and Section 8

Réf: 29652 Jeudi 20 Juin 2019 - En ligne

Overview: How does the new standard impact laboratories that are already accredited and how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits?   Why should you Attend: What are the changes to the technical and ...

Auditing Laboratories Conducting Assays Supporting Biologics

Réf: 29653 Jeudi 20 Juin 2019 - En ligne

Overview: Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the ...

Excel Spreadsheet Validation for FDA 21 CFR Part 11 (2019)

Réf: 29654 Vendredi 21 Juin 2019 - En ligne

Overview: These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.   Why should you Attend: Part 11 / Annex 11 Computer Systems Validation (CSV) is to ...

Responsibility for Off-label Claims in Social Media

Réf: 29655 Mardi 25 Juin 2019 - En ligne

Overview: One big issue is how you patrol and control what someone else is saying about your product in a public forum. Once the off-label information is out there, what is scope your responsibility?   Why should you Attend: What is considered "off-label" Using social media website ...

Canadian Drug and Health Products Regulatory Landscape

Réf: 29656 Mardi 25 Juin 2019 - En ligne

Overview: The focus will be on drugs, biologics and medical devices, We will also be providing an overview of how the regulatory landscape is currently evolving for most efficient strategic planning.   Why should you Attend: This webinar will give you a snap shot of what is current, ...

Investigation and Root Cause Analysis to Meet FDA Expectations

Réf: 29657 Mercredi 26 Juin 2019 - En ligne

Overview: This live interactive presentation will also discuss the regulations associated with the detection, correction and prevention of human errors in GMP manufacturing and laboratory processes.   Why should you Attend: We will focus on improved techniques to get to the real ...

FDA Inspections: From SOP to 483 in (2019)

Réf: 29658 Vendredi 28 Juin 2019 - En ligne

Overview: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?   Why should you Attend: This session will discuss how to prepare for ...

Machine Learning Tutorial for Beginner to Advanced Simpliv

Réf: 26894 28/03/2018 -> 31/12/2019 - En ligne

Machine Learning Tutorial for Beginner to Advanced Simpliv

The Complete Python 5 Course Beginner to Advanced Simpliv

Réf: 26895 28/03/2018 -> 27/12/2019 - En ligne

The Complete Python 5 Course Beginner to Advanced Simpliv

How does compliance with 21 CFR Part 11 help ensure data integrity and subject safety in clinical research

Réf: 27324 25/05/2018 -> 28/08/2020 - En ligne

Electronic medical records and electronic handling of study data is increasingly common.

To involve computer systems in clinical research implies knowledge of 21 CFR Part 11(ELECTRONIC RECORDS; ELECTRONIC SIGNATURES) and all of the ramifications of this Part of the code is essential. Basically elec

Advanced Spine Surgery in India

Réf: 29447 03/04/2019 -> 01/05/2020 - En ligne

Low Cost Spine Surgery in India