ICH Q9 provides guidance for quality risk management in the pharmaceutical industry. It encourages companies to implement quality by design from development through production to build quality into their processes and products. This helps reduce risks and allows for more efficient monitoring. While some companies fear changing processes may not be understood by FDA inspectors, proper documentation of scientific rationale is important. Strategies that mitigate multiple risks at once can help address areas of highest risk while supporting FDA compliance and inspection. ICH Q9 aims to foster both efficient operations and regulatory compliance in the competitive pharmaceutical industry.
Hot Potato Of Responsibility Edu Quest AdvisoryEduQuest, Inc.
EduQuest Advisory for "how to manage outsourcing and not get burned" written by Martin Browning, former FDA investigator and the co-founder and president of EduQuest.
Regulatory Challenges: Lecture @ University of Michigan 21 Feb 2013Ajaz Hussain
To frame the current challenges in (the implementation of) Pharmaceutical QbD in a manner that will provide you an opportunity to:
(1) Leverage prior learning about medical device QSR to inform and understand key issues in regulation of pharmaceutical QbD
(2) Provide an example of a ‘real world’ uncertainty that you should not hesitate to take-on based on the fundamentals of engineering science and practices you have learned
Hot Potato Of Responsibility Edu Quest AdvisoryEduQuest, Inc.
EduQuest Advisory for "how to manage outsourcing and not get burned" written by Martin Browning, former FDA investigator and the co-founder and president of EduQuest.
Regulatory Challenges: Lecture @ University of Michigan 21 Feb 2013Ajaz Hussain
To frame the current challenges in (the implementation of) Pharmaceutical QbD in a manner that will provide you an opportunity to:
(1) Leverage prior learning about medical device QSR to inform and understand key issues in regulation of pharmaceutical QbD
(2) Provide an example of a ‘real world’ uncertainty that you should not hesitate to take-on based on the fundamentals of engineering science and practices you have learned
When finding the fastest path between discovery and delivery, pharmaceutical companies are increasingly looking toward Contract Research Organizations (CRO s).
As the face of the industry changes, 2020 Pharma (Ph) sits down with two CRO experts to discuss these trends.
Part of the MaRS Entrepreneurship 101 series:
http://www.marsdd.com/ent101
Speaker: Michael H. May PhD
President & Co-Founder, Rimon Therapeutics Ltd.
This is available as an audio presentation:
http://www.marsdd.com/ent101 and click on the October 10, 2006 session, "Entrepreneurship 101 - Science and business do mix: success story"
Thinking Beyond Compliance Medical Device WhitepaperJenna Dudevoir
This white paper is based on a research study with leading medical device companies - from startups to multibillion dollar enterprises - to explore how they are balancing new product development with compliance requirements.
Developing a QMS in an FDA-Regulated IndustryEMMAIntl
No matter what scope your product falls under (medical device, drug, biologic, IVD) the regulatory requirements for your Quality Management System are strict. The FDA established its various Codes of Federal Regulations to enforce that a QMS is not just a “nice-to-have” for the life-science industry, it is the law. To me, however, a QMS should do more than just check a box for the FDA. Your QMS should be optimized towards your actual operations, to ensure it fulfills its purpose of supporting the several GxP standards, and ultimately facilitates your organization in creating safe and effective products...
Pharmacovigilance Conference on Drug Safety to be held in Jan 2010 at Mumbai, Provenance Research and www.pharmacovigilance.co.in are proud media partners
When finding the fastest path between discovery and delivery, pharmaceutical companies are increasingly looking toward Contract Research Organizations (CRO s).
As the face of the industry changes, 2020 Pharma (Ph) sits down with two CRO experts to discuss these trends.
Part of the MaRS Entrepreneurship 101 series:
http://www.marsdd.com/ent101
Speaker: Michael H. May PhD
President & Co-Founder, Rimon Therapeutics Ltd.
This is available as an audio presentation:
http://www.marsdd.com/ent101 and click on the October 10, 2006 session, "Entrepreneurship 101 - Science and business do mix: success story"
Thinking Beyond Compliance Medical Device WhitepaperJenna Dudevoir
This white paper is based on a research study with leading medical device companies - from startups to multibillion dollar enterprises - to explore how they are balancing new product development with compliance requirements.
Developing a QMS in an FDA-Regulated IndustryEMMAIntl
No matter what scope your product falls under (medical device, drug, biologic, IVD) the regulatory requirements for your Quality Management System are strict. The FDA established its various Codes of Federal Regulations to enforce that a QMS is not just a “nice-to-have” for the life-science industry, it is the law. To me, however, a QMS should do more than just check a box for the FDA. Your QMS should be optimized towards your actual operations, to ensure it fulfills its purpose of supporting the several GxP standards, and ultimately facilitates your organization in creating safe and effective products...
Pharmacovigilance Conference on Drug Safety to be held in Jan 2010 at Mumbai, Provenance Research and www.pharmacovigilance.co.in are proud media partners
Upfront Communication Makes for Better Medical Device Manufacturing - Tom Bla...marcus evans Network
Tom Black a speaker at the marcus evans Medical Device Manufacturing Summit Fall 2012 and the Medical Device R&D Summit Fall 2012, on how being prepared and having an innovative outlook can bring about further opportunities in the medical device manufacturing industry.
Interview with: Tom Black, Vice President, Original Equipment Manufacturer & International Divisions Sales and Marketing, B. Braun Medical Inc.
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The notion ‘by design’, in the phrase ‘Quality by
Design’, conveys an intention to deliver a product
or service with a pre-defined ‘quality’ so as to satisfy
intended customers. When the quality of a medicinal
product is considered, customer satisfaction
is often not easily measured. Therefore, regulatory
approval is important, and, it may be viewed as a
surrogate for confidence and satisfaction patients
and their physicians perceive.
This SWISS PHARMA presentation by
the author on 25 May 2012, in Basel, explored the
potential role of mathematical modeling tools, categorized
as Chemometrics, Pharmacometrics and
Econometrics, in improving regulatory communications
on ‘quality by design’. This article provides a
summary of arguments outlined during this presentation.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityAjaz Hussain
25 May 2012 Basel, Switzerland. A philosophical exploration - Scientific understanding and risk-based regulatory decisions on Quality by Design. How good are the scientific explanations in regulatory submissions? Scientific explanations yield understanding; quality of explanations differ.What role can Chemometrics, Pharmacometics and Econometrics play? Understanding multidisciplinary (cGMP, CMC, Clin. Pharm., Tox., Clinical, Public Health) perspectives on risk is important. Opportunities; only when the disciplinary divides are bridged. Within the regulatory realm how we set specifications and assess risk have progressed incrementally; at this rate the Vision 2020 may be expected to be visible broadly over time, by 2020?
Integrity driven performance in the pharmaceutical industryOnly Medics
The foundation of any sustainable and profitable business model requires the trust of consumers, regulators, investors, and creditors. Relative to their counterparts in other sectors, however, pharmaceutical companies find themselves party to a more involved and demanding social contract. The public expects pharmaceutical companies to address social needs as well as earn a financial return.
How to Implement and Maintain an Audit-Ready QMS Leveraging TechnologyGreenlight Guru
Despite ever-changing and increasingly complex medical device regulations, many companies have built their compliance systems on risky paper-based quality systems or legacy, general-purpose software not built for med device. You can do better.
Inefficient systems increase your risk of noncompliance and increase your development time. That translates into missed sales opportunities and patients waiting longer for your new medical technologies.
So we’ll show you a modern, purpose-built software that ensures compliance with all the latest regulations to free up your engineers’ time, reduce risk, time to market, and help you pass audits with flying colors.
• Step-by-step instructions on how to implement and maintain an audit-ready QMS leveraging Jon’s S.M.A.R.T. quality management philosophy
• How to accelerate product development efforts — from napkin idea to 510(k) clearance to market release months or years quicker
• How to manage risk to drive the safety and quality of products and processes through QMS per ISO 13485:2016 & 21 CFR Part 820
• How to change their company’s focus from simply meeting regulations to building quality into their processes as a differentiator
• How to understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
While Lean Sigma is not a silver bullet for driving business performance improvement, it is a key element of a high-performing business ecosystem which provides the ongoing catalyst to drive innovation while also improving business outcomes.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Company Valuation webinar series - Tuesday, 4 June 2024FelixPerez547899
This session provided an update as to the latest valuation data in the UK and then delved into a discussion on the upcoming election and the impacts on valuation. We finished, as always with a Q&A
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Holger Mueller of Constellation Research shares his key takeaways from SAP's Sapphire confernece, held in Orlando, June 3rd till 5th 2024, in the Orange Convention Center.
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1. Risk Management:
Applying ICHQ9 to the
Pharmaceutical Business
Since the late 1970s, the pharmaceutical industry UNDERSTANDING ICHQ9 Pharmaceutical Technology Institute at Xavier
has been looking for guidance. Before they can In Nov. 2005, ICH issued a document to guide University. “They’re trying to prepare for when the
release new drugs to consumers, these companies Quality Risk Management (ICHQ9). Historically, FDA walks through their doors.”
need to know how to maintain compliance with companies have prepared for FDA inspections by However, the FDA is encouraging companies to
somewhat vague regulations from the FDA. But in reviewing their competitor’s FDA reports to find focus on their internal processes and systems in
an increasingly competitive landscape, they also out what the FDA is evaluating. order to:
need to know how to succeed as a business. “They try to adjust their procedures, their prac- • Build quality into the process and product
Rather than asking the FDA to update their tices and their systems to fall in alignment with (known as “Quality by Design” or “QbD”) from
regulations, The International Conference on what they’re hearing that the FDA is interested in,” the development stages forward, rather than
Harmonisation of Technical Requirements for says Marla Philips, PhD and director of the waiting until the end of production to test the
Registration of Pharmaceuticals for Human Use
quality of the product.
(ICH) gathered input from experts within the
industry. Through a series of documents, ICH can • Reduce overall risk and implement continuous
help these companies understand how FDA regula- QbD monitoring to ensure their risk strategy’s
tions fit within the business of pharmaceuticals.
ICH can help companies effectiveness and to prevent the introduction
of new risks.
These documents allow companies to learn from
each other, maintain compliance based on avail-
understand how FDA
• Improve antiquated processes and analytical
able company resources, and evaluate their current
processes with a clearer understanding of FDA reg-
regulations fit within the methods in order to improve consistency of
quality, which may lead to a more efficient—
ulations. pharmaceutical business. and therefore more cost-effective—process.
The Xavier Leadership Center, Exponent 8 Fall 2008
2. MITIGATING RISK CONCERNS ABOUT APPLYING Q9
“The safest way [to mitigate risk and maintain
There’s a need to not Since most FDA inspectors do not have industry
compliance],” according to Philips, “is to stick
with something the FDA is comfortable with. If
only deliver a product experience, some companies are afraid to change
from an existing process to one that—while scien-
they come in and see a process they’re not com- that’s effective, but also tifically equivalent—may not be easily understood
fortable with, your product may not be approved. by inspectors who lack the experience to under-
And every day that it’s not approved is big money to be more efficient. stand the scientific justification. But many compa-
lost.” nies do not sufficiently document scientific
For the sake of ensuring FDA compliance and rationale and justification. Without this documen-
mitigating risk, companies are encouraged to ana- tation, they cannot maintain GMP compliance and
lyze their existing systems, evaluate risks within DEVELOPING STRATEGIES inspectors cannot determine if the rationale is sci-
those systems and assign resources to address entifically sound.
Some QRM strategies may help to mitigate numer-
those risks. “[ICHQ9] is not new information in general, but
ous risks at once. “When you develop a strategy
“[The FDA has] inspectors who’ve been in the it’s important to the FDA regulators and to the
for one risk,” notes Philips, “it could mitigate
industry for years,” says Philips, “and they might overall pharmaceutical industry. If the FDA can
another. Think through proactively. Ask yourself
go in and be looking for these same [old process- inspect more companies with fewer inspectors, and
what’s involved?
es] and not be comfortable trying to understand if technically advanced processes can be made
If you change one thing, how does it cascade
the scientific justification [of the new process].” more efficient, then prescription drug costs can go
through? Or if you cover another risk more
Both the companies and the inspectors want to down. And by instituting QbD, consumers can still
intensely, what other risks are covered?” As you
maintain existing processes that have been shown have safe and effective drugs.”
develop QRM strategies, focus your resources on
to support compliance and have been historically
areas of highest risk. And as you apply ICHQ9 to
accepted by FDA inspectors. But in a competitive
your business, make sure you can help FDA inspec-
industry, these standard processes may not be
tors understand and accept your QRM processes.
enough.
STAYING COMPETITIVE AND COMPLIANT
Understanding that companies need to make a
profit while staying compliant, the FDA issued
High
“cGMPs for the 21st Century” to address current
good manufacturing practices in the pharmaceuti-
cal industry. Through this document, the FDA is
driving efficiencies in the operation of a pharma-
ceutical business while fostering compliance with
Mitigate Avoid
FDA regulations. According to Philips, there’s a
Probability
need to “not only deliver a product that’s effec-
tive, but also to be more efficient. Because when
we don’t, people are paying more money for their
prescriptions and the government is getting a lot
of flack for that. These political pressures are part
of [the FDA’s] drive to focus on risk management.”
It’s also a question of available resources. The
FDA doesn’t have enough inspectors to evaluate
every company, not only within the United States
but internationally as well. With many pharmaceu-
tical companies outsourcing various parts of their Accept Transfer
operation, the FDA has to make strategic decisions
about which sites to evaluate. “They’ll generally
look at sites involved with making sterile prod-
Low
ucts,” says Philips. “They don’t have the resources
to inspect all the companies, but they hold the
parent companies responsible for compliance of all
these companies [they outsource to].”
Low High
Impact
Managing multiple risks requires a strategy that considers the probability and impact of the risk, as well as the
detectability of the event. Companies should focus resources on risks that have high probability and high
impact, while maintaining an effective continuous monitoring system to monitor all identified risks.
Are you interested in learning more about risk
management in the pharmaceutical industry?
Visit www.xavier.edu/xlc to learn more about Xavier Leadership Center’s Pharmaceutical Technology Institute today.
The Xavier Leadership Center, Exponent 9 Fall 2008