December 7, 2017
By Betsy Fallen, BAFallen Consulting LLC
Just about everyone in the drug development industry has cited 21 CFR Part 11 at one time or another. Fondly referred to as “Part 11,” the August 1997 regulation was last referenced by the FDA in 2003 with the release of a Guidance for Industry - Part 11, Electronic Records; Electronic Signatures — Scope and Application.1 Since then, the centralized research team has significantly changed from only a few stakeholders into a system of many globally distributed contributors. The industry’s documentation has transitioned from paper files to dynamic, integrated systems supporting digital records spanning the bedside to the research clinic. The delivery of healthcare has evolved from the confines of brick and mortar to cloud-based platforms that could only be dreamed of a few years ago.
According to a recent AberdeenGroup report, life science companies face pressures that "typical" manufacturers do not. These pressures include "complying with government regulation and providing traceability in their operations." Because of these pressures, life science companies often stand at a mediocre level in terms of first pass yields, overall yields, and DPMOs (defects per million opportunities).
December 5, 2017
By Michelle Lott, Principal and Founder, Lean RAQA
Manufacturers everywhere have been waiting a year and a half for additional guidance on the requirements of ISO 13485:2016, hoping September’s release of the "ISO 13485:2016 – A Practical Guide" (hereafter known as the “Practical Guide” or “Guide”) would bring the “practical” guidance promised.
October 31, 2017
By Craig Morgan, Head of Marketing, goBalto
For clinical research, Study Startup (SSU) is the pivotal period that lays the groundwork for a successful study. By ensuring that the right sites are selected and target subjects are recruited in a timely and cost-effective manner, mission critical risks can be avoided that lead to runaway costs and delays.
October 24, 2017
By Wolfgang Schmitt, Vice President, Concept Heidelberg
Both the European Compliance Academy (ECA) and the European Qualified Person association (EQPA) are often contacted by people who would like to become a Qualified Person (QP according the EU Directives) outside of the EU. Is this possible?
October 17, 2017
By Peter Knauer, Managing Partner and Co-Founder, Sage BioPartners
Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?
September 21, 2017
By Laurie Meehan, Social Media Manager, Polaris Compliance Consultants
You use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.
September 10, 2017
By Dave Richardson, Senior Analyst, Cutting Edge Information
It's no secret that pharmaceutical companies have great concerns about their overall compliance efforts. In fact, in several conversations that I've had with executives from marketing, sales, clinical, medical and other functions, it's rare to hear that compliance isn't a hot-button issue.
September 1, 2017
By David Cornwell, Founder/CEO, PleaseTech Ltd.
This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.
When an FDA inspector comes to your door, it is usually a time of stress and uncertainty. You need to handle logistical elements like where the inspectors are going to be placed, how you.
August 24, 2017
By Stephanie Gaulding, CQA, CPGP, DPS Engineering
I had the pleasure spending two days networking and discussing quality metrics and quality culture with industry and FDA leadership at PDA's 2017 Quality Metrics and Quality Culture Conference last February. This year's conference included some of the most candid and honest dialog on these topics that I've seen between industry and FDA to data. I thought I would share some of the messages and my takeaways from the two-day event.
August 14, 2017
By Steve Tyrell, Senior Director, Business Development, Regulatory Compliance Associates Inc. and Lisa L. Michels, General Counsel and Regulatory Affairs Expert, Regulatory Compliance Associates Inc.
Insights on working with regulatory bodies on novel devices such as artificial intelligence, machine learning and algorithms.
July 11, 2017
By Keith Matthews, Director Quality Systems, Regulatory Compliance Associates Inc.
Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction. Throughout the organization’s lifecycle, from start-up through maturity, the quality needs of the firm, along with its budget constraints, are continually evolving. Maintaining compliance with regulations while controlling costs represents a challenging balancing act we encounter in our life science consultancy.
June 15, 2017
By Susan Schniepp, Distiguished Fellow at Regulatory Compliance Associates, Inc
One of the most discussed and debated topics on today’s pharmaceutical landscape is the issue of quality metrics. Establishing, maintaining, and interpreting quality metrics to determine the suitability of pharmaceutical products has become a high priority for the FDA. To understand the issue of quality metrics it is important to start at the beginning.
June 8, 2017
By Vivian Bringslimark, President and Owner, HPIS Consulting, Inc.
While training may appear to be straightforward to most leaders, the effectiveness follow up is anything but clear-cut. So why do business leaders frown when the answer to the training effectiveness question is – it depends?
Patients of Alzheimer’s disease, their families, and health care advocates recently encountered back-to-back disappointments when two clinical trials for Alzheimer’s drugs failed in quick succession. First, Eli Lilly & Co. stopped its late-stage clinical trial for solanezumab, then Merck & Co. ended its clinical trial for verubecestat. Both studies failed to show efficacy.
May 23, 2017
By Marci Crane, Staff Writer, MasterControl
It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.
