Past Events (3,027)

6-Hour Virtual Seminar - Batch Record Review and Product Release

June 28, 2021 from 8am to 2pm – Online event Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures f… Organized by John Robinson | Type: online, event

6-Hour Virtual Seminar on Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties

June 25, 2021 from 8am to 2pm – Online event The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, e… Organized by John Robinson | Type: online, event

Method Development and Validation for Assays Supporting Testing of Biologics

June 24, 2021 at 9am to June 25, 2021 at 5pm – online Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support develo… Organized by ComplianceOnline | Type: seminae
6-Hour Virtual Seminar on EU Regulatory Affairs Strategy During Development of Medicinal Products

June 24, 2021 from 8am to 2pm – Online event The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects t… Organized by John Robinson | Type: online, event

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

June 23, 2021 from 8am to 2pm – Online event This seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage an… Organized by John Robinson | Type: online, event

6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

June 22, 2021 from 8am to 2pm – Online event If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the re… Organized by John Robinson | Type: online, event

Human Error Reduction Techniques for Floor Supervisors

June 17, 2021 from 10am to 1pm – online Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to c… Organized by ComplianceOnline | Type: seminae
Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines

June 17, 2021 at 10am to June 18, 2021 at 5pm – online Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to h… Organized by ComplianceOnline | Type: seminae

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

June 14, 2021 at 10am to June 15, 2021 at 4pm – online The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appr… Organized by ComplianceOnline | Type: seminae
Designing and Sustaining New and Existing Product Stability Testing Program

June 14, 2021 at 9am to June 15, 2021 at 4pm – online This Virtual Seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries i… Organized by ComplianceOnline | Type: seminae