The Top 6 Risk Management Themes

The Risk Revolution series, part of the Voices in Validation podcast, uncovers the latest challenges in risk management, with the goal of advancing the maturity of risk management practices within the industry by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and...

PQ Forum #23. PQ Documents List In Validation Plan

“PQ Forum” provides a mechanism for validation practitioners to share information related to Stage 2 Process Qualification in the validation lifecycle. Information about supporting activities such as design and development, equipment, and analytical validation will also be shared. The information provided should be helpful and practical so as to...

MR #4. Mutual Respect Within Department Teams

Discussion of non-technical management topics is always an area of interest in validation and QA professional meetings. Validation and QA functions are vital functions at a regulated manufacturing site. Validation and QA management must continually work to create a positive work environment in their respective functions. Mutual respect between...

Explicit Microsoft Excel Methods For Computerized System Validation

To combat CSV non-compliance, established here are cost and time effective explicit methods to verify and validate Microsoft Excel Workbooks designed to meet standards set by Australian regulatory bodies: The Therapeutic Goods Administration (TGA) and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

How To Ensure Senior Management Approval For Your Next Regulated IT System

Senior Leadership has to make hard decisions about investments. We see headlines about mergers, acquisitions, partnerships, opting in on products that have exciting development or preclinical results. The headlines may also include significant investment in internal infrastructure. Hundreds of millions of dollars may be directed to building a new facility to manage the increased demand of an existing product or to prepare for a clinical candidate showing a high probability of success.

PQ Forum #21 - Validation Initiation Document Template

Validation documents are key documents in a pharmaceutical manufacturing facility. Validation documents must be carefully written for internal and external review including audit by regulatory inspectors; they may be accessed numerous times during a product lifetime. The most frequently reviewed validation documents are Stage 2 Process Performance Qualification documents.

How to Implement the ISPE Commissioning and Qualification Baseline Guide

Commissioning, Qualification, and Validation (CQV) has undergone dramatic changes and challenges over that last couple of decades driven by competing priorities, misperception about global regulatory requirements, and fear of change. Several guidances and standards have been published to provide ideas and approaches to the implementation of an...

How To Ensure Senior Management Approval For Your Next Regulated IT System

Senior Leadership has to make hard decisions about investments. We see headlines about mergers, acquisitions, partnerships, opting in on products that have exciting development or preclinical results. The headlines may also include significant investment in internal infrastructure. Hundreds of millions of dollars may be directed to building a new...

PQ Forum #21 - Validation Initiation Document Template

Validation documents are key documents in a pharmaceutical manufacturing facility. Validation documents must be carefully written for internal and external review including audit by regulatory inspectors; they may be accessed numerous times during a product lifetime. The most frequently reviewed validation documents are Stage 2 Process Performance...

How to Implement the ISPE Commissioning and Qualification Baseline Guide

Commissioning, Qualification, and Validation (CQV) has undergone dramatic changes and challenges over that last couple of decades driven by competing priorities, misperception about global regulatory requirements, and fear of change. Several guidances and standards have been published to provide ideas and approaches to the implementation of an adequate risk-based approach to CQV.