Conference Coverage and Freelance Writing

Producing professional reports on conference sessions

 As Chief Information Officer and Senior Editor at International Pharmaceutical Quality (IPQ) for six years, I traveled internationally to conferences, attending sessions and conducting interviews to produce in-depth reports on topics of interest to both industry and regulators in the drug GMP and CMC space. I developed a clear and concise writing style to convey complex ideas and relationships in simple terms.   I can cover your conference events and produce professional reports on the content.  Contact me for more information.  See recently published articles below.

FDA’s Top Ten Drug GMP Inspection Citations FY 2017 and Analysis

  

At the FDA/Xavier PharmaLink conference at Xavier University in Cincinnati, Ohio, in March 2018, Dell Moller and Nicholas Paulin presented FDA’s top ten drug GMP inspection citations for FY 2017 and participated in a panel discussion that provided insight into the observations.


Moller is an FDA Supervisory Investigator based in Columbus, Ohio. Paulin is a Drug Specialist and Pre-Approval Manager at FDA’s Cincinnati District Office. 


Read the complete article here.

FDA Presents Case Study of Firm with a History of Non-Compliance FY 2016

 

At the FDA/Xavier PharmaLink conference at Xavier University in Cincinnati, Ohio, in March 2017, FDA National Expert Investigator Robert Tollefsen presented a case study on a pharma company with compliance problems, and led a group discussion with the audience on what the appropriate actions would be for the company to undertake, given the circumstances.


The presentation took place as part of a panel discussion that also included FDA Cincinnati District Supervisory Investigator Dell Moller, and Elanco QA Compliance and Auditing Regulatory Surveillance and External Engagement’s N. Brent Conatser. At the same session, Moller gave a presentation on the top ten FDA inspection findings in FY 2016. [Authored by Jerry, submitted by Brent.] 


Read the complete article here.

Planned CDRH Reorganization Will Impact Device Approvals and Inspections

The FDA Center for Devices and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of expertise into a new office that aligns talent into teams by product type and technology.  Individuals from the evaluation and compliance groups for specific product types and technologies will be on one team, creating a new review and inspection dynamic.


Read the complete article here.

How AI Tools Will Transform Quality Management In The Life Sciences

FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.


Read the complete article here.

Where No GMP Inspector Has Gone Before (Or At Least Very Few)

What happens when a company submitting a marketing application for a drug is located in a country with an unstable and hostile environment, but an inspection of the manufacturing facility needs to take place to approve the application? 


Read the complete article here.

Published Articles, Continued

MHRA Ramps Up Data Integrity, Global Supply Chain Security Efforts

Major efforts are underway by health regulatory authorities around the globe to secure drug and device supply chains and address the quality of data in approval applications and manufacturing operations.


At the FDA/PharmaLink Conference at Xavier University in March, U.K. Medicines and Healthcare products Regulatory Agency (MHRA) Senior GMDP (good manufacturing and distribution practices) Inspector Tracy Moore discussed MHRA’s efforts regarding supply chain security and international efforts on harmonization of data integrity guidance.


Read the complete article here.

How FDA and MHRA Decide Which Drug Facilities To Inspect — And How Often

 The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. In concert with the method revamp, the agency introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.


At the FDA/Xavier PharmaLink conference at Xavier University in Cincinnati, Ohio, in March, FDA Office of Surveillance (OS) Senior Advisor Beth Philpy discussed the recent changes, why they were enacted, and the impact they will have on the pharmaceutical industry. OS is part of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ), and it is responsible for coordinating drug inspections.  Both offices were created in 2015.


Read the complete article here.

How FDA, Industry, And Academia Are Guiding AI Development In The Life Sciences

  Continuously learning systems (CLS) have shown great promise for improving product quality in the pharmaceutical and medical device industries. These artificial intelligence (AI) algorithms constantly and automatically update themselves as they recognize patterns and behaviors from real-world data, enabling companies to become predictive, rather than reactive, when it comes to quality assurance. However, the output for the same task can change as a CLS algorithm evolves. This stands in sharp contrast to systems traditionally used in the life sciences, which are validated and expected to not change — performing exactly the same way each time they are used.


A team of FDA officials and industry professionals working through Xavier Health’s Artificial Intelligence (AI) Initiative are tackling this issue by developing good machine learning practices (GmLPs) for the evaluation and use of CLS. A primary objective of the Xavier Health CLS Working Team has been to identify how one can provide a reasonable level of confidence in the performance of a CLS in a way that maximizes the advantages of AI while minimizing risks to product quality and patient safety. (A second Xavier Health team of industry professionals is actively exploring the use of AI for continuous product quality assurance (CPQA), as discussed in a previous article.)


For the complete article, click here.

Pharma Quality Systems Need Revamping To Accommodate Digital Health Tech

  As pharmaceutical companies develop and market more medical devices and combination products with digital health components, the FDA and industry experts are cautioning that the associated frequent software changes, software maintenance, and cybersecurity can carry significant regulatory and business risks.


In addition, bringing software into a pharma quality system has challenges similar to those that companies face when moving into the medical device arena, as the language, regulation, development timelines, and need for human factors studies differ greatly from what traditional pharma is used to.


This two-part article addresses the issues that pharma companies face when moving into the digital health space. This first installment explores the development process, agency guidance, and need for quality oversight for software incorporated into medical device and combination products.


For the complete article, click here.

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Published articles, continued

How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence. The AI tool will replace a manual, labor-intensive process with one that can look across large data sets and find correlations between obscure signals and events which the previous system could have missed.


In creating the AI tool, the team used agile software development. Agile development is an iterative approach under which requirements and solutions evolve through the collaborative effort of cross-functional teams and their end users. It involves an incremental development strategy, meaning each successive version of the product is usable and each builds upon the previous version by adding user-visible functionality.


Because the deviation reports — which Amgen calls non-conformance (NC) reports — are documents containing mostly text, the project team decided to employ an AI tool called natural language processing (NLP) to examine them. NLP provides a way for computers to analyze, understand, and derive meaning from human language, including not only words but also concepts and how they are linked together to create meaning.


For the complete article, click here.

Planning Ahead for Transition to the EU’s MDR: A How-To Guide, Part 1

Preparing for compliance with the European Union’s (EU) Medical Device Regulation (MDR) is proving challenging for medical device manufacturers as meeting the rapidly approaching deadline (May 2020) for coming into operation is requiring more time and resources than many anticipated from an initial read of the regulation.


New provisions in the EU MDR may necessitate additional clinical testing, changes to supply chain partners, registering products that were not previously covered, dealing with device classification changes, additional post-market surveillance reporting, and quality system changes, among other changes, many of which are not obvious (see figure below).


For the complete article, click here.

Planning Ahead for Transition to the EU's MDR: A How-To Guide, Part 2

In a podcast earlier this year, Qserve’s Gert Bos gave an overview of some of the issues facing medical device manufacturers in complying with the Medical Device Regulation (MDR) in conjunction with an example roadmap companies can use to transition to the new requirements.


Bos posed two questions that he suggested device manufacturers ask themselves early on in the process of investigating the impact of the MDR:

 

• Do you know what percentage of your revenue is based on your European Union (EU) market approval?


• What will happen to your company if you lose that market share?


For  the complete article, click here.

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