Meetings/Workshops on Healthcare Systems and Hospital Management in the United States (USA)

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1
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH).
21 Sep 2020 - 22 Sep 2020 • Philadelphia, PA, United States
Organizer:
Complianceonline
Abstract:
Analytical methods should be validated to ensure the reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing or a transfer waiver, if justified. If a laboratory uses an alternative method instead of a compendial method, equivalence or superiority of the alternative method should be demonstrated.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Laboratory compliance, Analytical methods, data, procedures, compendial methods, Method validation and transfer, equivalency testing, FDA inspection, SOPs, FDA and EU compliance, documentation, ICH Q2, USP chapters 220, 1200, 1210, 1220, USP, >, GLP, GCP, GMP, FDA Warning Letters, Part 11, Annex 11, LOD, LOQ, HPLC to UHPLC, INDA, ANDA, NDA submissions, QbD, statistical evaluation, Training by, Analytic Lab workshop
Event listing ID:
1353810
2
Laboratory Inspection and Auditing
23 Sep 2020 • Philadelphia, PA, United States
Organizer:
Complianceonline
Abstract:
Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP regulations affecting pharmaceutical quality control, this one-day course is designed to provide the non-specialist with the necessary knowledge to understand the quality significance and risk associated with different analytical operations.
Contact:
Phone: [18887172436];     Email: referral@complianceonline.com
Topics:
"Lab safety audit checklist, laboratory audit checklist, chemical laboratory audit checklist, pharmaceutical quality assurance, pharmaceutical guidelines for quality assurance, quality control of drugs, gmp guidelines for pharmaceuticals, laboratory inspection
Event listing ID:
1324714
3
Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP
30 Sep 2020 • Palo Alto – online, United States
Organizer:
Complianceonline
Abstract:
This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.
Contact:
Phone: [18887172436];     Email: referral@complianceonline.com
Topics:
Process, Mapping, for, Risk, Based, P, PC, Using, Lean, Six, Sigma, and, HACCP, ComplianceOnline
Event listing ID:
1374449


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Last updated: 27 August 2020