Pharmaceutical Communiqué Q2 2017

Read up on Data Integrity, Using Analytics to View Qualification Trends,and The Post-Approval Inspection Process.

Health Care Communiqué Q1 2017

This communiqué discusses the The Future of Medicare Advantage Provider Directory Requirements, The 2016 Civil Monetary Penalties List, The First 2017 Audit Notices and more!

Medical Device Communiqué Q1 2017

Read up on Medical Device Single Audit Program, Case Study - MDSAP Audit Experience, and Using Visual Data Analytics of Qualifications

Pharmaceutical Communiqué Q2 2016

Read up on FDA imports alerts and cGMP compliance, the challenge of change management for data integrity,the visual SOP quiz best practices, and reporting post-approval changes to FDA.

Pharmaceutical Communiqué Q1 2016

Read up on cleaning validation, seven critical steps for data integrity, foundational EU regulatory knowledge, standardizing learning with governance policies, and GMP basics for combination products.

Medical Device Communiqué Q1 2016

Read up on IEC 61010 documentation requirements, key changes to ISO 13485:2016, how to standardize learning with governance policies, and GMP requirements basics for combination products.

Health Care Compliance Communiqué Q1 2016

This communiqué covers FCPA lessons from 2015, Life Sciences data theft and HIPAA, and DOJ expansion of FCPA resources.

Health Care Communiqué Q1 2016

This communiqué discusses the arrival of a new Gleevec generic, independent auditor validations, CMS Part D prescriber enrollment requirements, biosimilars, and the timeline for Q1 CMS due dates.