December 11, 2019
By Mike Rigert, Staff Writer, MasterControl
A recent U.S. Food and Drug Administration (FDA) report indicates one of the reasons for drug shortages in the U.S. is the absence of incentives for manufacturers’ facilities to go beyond minimal quality compliance. A proposed voluntary FDA ratings system based on objective criteria could potentially benefit and reward drugmakers for their facilities’ heightened quality manufacturing maturity.
September 24, 2019
By David Jensen, Staff Writer, MasterControl
Pharmaceutical manufacturing typically functions in a constant flurry of hard-to-satisfy demands, ranging from stringent compliance requirements and production schedules to developing strategies for continuous improvement. One of the presentations at the 2019 ISPE Annual Meeting and Expo, Oct. 27-30 in Las Vegas, will provide attendees with insight on how pharmaceutical companies are using digital technologies to avoid manufacturing obstacles while strengthening their competitive posture in the industry.
February 21, 2019
By Beth Pedersen, Staff Writer, MasterControl
Let’s face it, winter is a euphemism for cold and flu season. Much like these inconvenient and disruptive viral infections wreak havoc on the human body, paper-based batch record processes can infect a manufacturing floor, slowing and compromising an otherwise healthy operation. Fortunately, an electronic batch record (EBR) solution can cure the disease.
July 31, 2018
By Tifany Desprez, Apsalys, a MasterControl Partner
France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.
July 26, 2018
By Carla Frances Reed, President, New Creed
Pharmaceutical companies continuing the trend of mergers, acquisition and partnerships is creating challenges, opportunities and redundancies for supplier management. To meet these changing needs, it’s imperative that managers conduct supplier evaluation and rationalization processes and emphasize “good supply practices.” Learn some of these best practices and how to adapt them to your company.
July 12, 2018
By Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health
The second part of a two-part blog post that examines the importance of the emerging technology of artificial intelligence and the potential is has to bring about a massive shift in quality management for pharma and medical device manufacturers.
Xavier Health takes a closer look on how to prepare and assess the readiness of your company to implement AI.
July 10, 2018
By Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health
FDA officials believe that artificial intelligence (AI) has the potential to bring about a step change in quality management in the pharma and medical device industries. Xavier Health has assembled a team of multidisciplinary experts to take a closer at the possibilities and roadblocks AI presents to quality management in both industries. Part 1 of a two-part series.
June 14, 2018
By Jonathan M. Lewis, Prinicipal, Advanced Biomedical Consulting
A vendor qualification program is a practical and compliant methodology you can implement to vet and manage vendors and make well-informed purchasing decisions.
June 5, 2018
By Marci Crane, Staff Writer, MasterControl
Is the U.S. FDA about to approve the first cannabis-derived drug to win federal approval? In a recent FDA Advisory Committee meeting, a teenage boy addressed committee members. Sam, an epilepsy patient, was the first U.S. citizen to try Epidiolex, a cannabis-derived drug. Read about the future of medical marijuana.
May 22, 2018
By Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health
Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.
April 17, 2018
By Mike Rigert, Staff Writer, MasterControl
Get up to speed on key takeaways from what are expected to be some of the most tranformational trends to affect the pharmaceutical industry in 2018. And for further analysis of some of the top trends in pharmaceuticals this year, check out the associated white paper.
February 9, 2018
By Jake Walton, Corporate Operations Quality Manager, MasterControl
This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .
January 23, 2018
By Jake Walton, Corporate Operations Quality Manager, MasterControl
External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.
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 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.
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?
