All seminae Events (68)

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

January 11, 2022 from 10am to 1pm – online In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>… Organized by Complianceonline | Type: seminae

Analytical Instrument Qualification and System Validation

January 12, 2022 at 10am to January 13, 2022 at 5pm – online Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records mu… Organized by ComplianceOnline | Type: seminae

Complete 1099, TIN Matching, B-Notice, FATCA and Nonresident Alien 1042-S Compliance Update

January 13, 2022 at 8am to January 14, 2022 at 2pm – online The average cost of a Notice of Proposed Penalty is estimated at US $150,000 including the penalty itself and the added costs for consultants, personnel, remediation of legacy records, etc. Complianc… Organized by ComplianceOnline | Type: seminae

Verification and Validation - Product, Equipment/Process, Software and QMS

January 18, 2022 at 9am to January 19, 2022 at 4pm – online Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-b… Organized by Complianceonline | Type: seminae

Statistical Elements of Implementing ICH Guidelines

January 19, 2022 at 10am to January 20, 2022 at 4pm – online Why Should You Attend: Most organizations have programs and procedures but they contain holes or fall short in the implementation of the tools and techniques used to apply proper statistical reasonin… Organized by Complianceonline | Type: seminae

Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions

January 20, 2022 at 8:30am to January 21, 2022 at 2:30pm – online The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relyi… Organized by Complianceonline | Type: seminae
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach

January 20, 2022 at 9:30am to January 21, 2022 at 4:30pm – online The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure… Organized by Complianceonline | Type: seminae

A risk based approach to GxP Compliant Laboratory Computerized Systems

January 24, 2022 at 11am to January 25, 2022 at 5pm – online Laboratory Computerized Systems and data management operations are increasing in variety, sophistication and complexity in the GxP environment. Widespread reliance on these systems, along with their… Organized by Complianceonline | Type: seminae
A risk based approach to GxP Compliant Laboratory Computerized Systems

January 24, 2022 at 11am to January 25, 2022 at 5pm – online Laboratory Computerized Systems and data management operations are increasing in variety, sophistication and complexity in the GxP environment. Widespread reliance on these systems, along with their… Organized by ComplianceOnline | Type: seminae
The Drug Development Process from Concept to Market

January 24, 2022 from 11am to 5pm – online This course is designed to cater for employees of pharmaceutical companies who would like an understanding of the drug development and regulatory approval process. The course starts by considering th… Organized by Complianceonline | Type: seminae