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“Combination Products: What You Need to Know” Seminar for Medical Device, Pharmaceutical Manufacturers is Scheduled for October 31st in Boston
A full-day technical seminar
designed to assist medical device and pharmaceuticals with what they need to
know about manufacturing combinations products, including best practices and applicable
FDA regulations, is scheduled for Thursday, October 31st, in
Waltham, Mass., just outside Boston.
Combination
products are a large and growing segment of the medical device market. Some
analysts estimate they represent more than 30% of all new FDA product
submissions. But for manufacturers, the convergence of drugs, biologics, and
devices presents a host of best practice and regulatory issues.
Titled “Combination Products: What You Need to Know,”
the seminar will outline a realistic approach for manufacturers
to navigate the testing, production, and regulatory standards related to the manufacture
of combination products. Topics will include:
- Combination Products —What You Need To
Know:
Overview of regulatory hurdles for combination products highlighting the
determination of PMOA.
- Applications of Lean to Combination
Product Manufacturing: Case studies specific to applying lean to
manufacturing of combo products for clinical use.
- In-Process and Release Testing PTC: Outline of
in-process and release testing points to consider during development and
specification determination.
- EM Monitoring of GMP Manufacturing
Space:
Current EM procedures for setting up GMP manufacturing.
- Choosing the Right CMO: Discussion of
best practices to determine a right fit CMO.
“Combination Products: What You Need to Know,”
will be presented by Microtest Laboratories, a leader in
testing services and contract manufacturing for the medical device,
pharmaceutical, and biotechnology industries. The seminar will be held at the Conference Center at Waltham Woods in Waltham, Mass., just
outside Boston, on Thursday, October 31, 2013, from 9:00 a.m. to 3:00 p.m. Registration
is at 9:00 a.m. Continental breakfast, break refreshments
and luncheon is included.
The seminar is one
in a continuing series of technical events presented by Microtest Laboratories for
medical device and pharmaceutical manufacturers. The seminars tend to fill up
quickly so please register early! Follow Microtest Laboratories on Facebook at http://goo.gl/pHNP63, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.
Labels: best practices, Boston, combinations products, FDA regulations, manufacturing, Mass, medical device, pharmaceuticals, seminar, technical seminar, Waltham
Industry Perspective on Reusable Medical Device Cleaning and Validation Requirements Outlined in New Management Brief
“Although the FDA guidance
document is not legally enforceable, it describes the agency’s ‘current
thinking and should be viewed as recommendations,’” said Steven Richter,
Ph.D., president and scientific director of Microtest Laboratories — a former
FDA official — and author of the brief.
- “Spore tag
reduction” and Hucker’s soil challenges
- Cleaning
methods using protein, carbohydrates, red blood cells and lipids
- Separation of cleaning,
disinfectant and sterilization validation activities
- ASTM Simulated
Use Test
- Three log
reduction for cleaning validations
- Empirical data
in 510(k) submissions
- Reducing manufacturing
materials to “safe levels”
While Richter emphasized that “the
FDA document was issued for comment and is not for implementation, the medical
device industry understands that changes from current best practices will be
required immediately.”
His brief seeks to “raise the
industry discussion of issues that must be anticipated, discussed, and thoroughly
evaluated for the time when implementation is required,” he said.
Dr. Richter founded Microtest Laboratories in 1984 after a
distinguished career at the FDA. Under his leadership, Microtest Laboratories
provides the medical device, pharmaceutical, and biotechnology industries with
premier testing and manufacturing support.
Microtest Laboratories, based in Agawam, Massachusetts, is a full-service
medical device testing laboratory and a leader in medical device testing and
related services for the medical device, pharmaceutical, and biotechnology
industries. Testing is performed in-house by seasoned regulatory
microbiologists and chemists under strict GMP/GLP regulations. Microtest is
both ISO 9000 and 17025 certified. Testing services include bioburden,
sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition,
Microtest recently introduced a fast-track test to screen plastics and polymers
in medical devices for toxicity using Zebrafish embryos.
# # # Labels: cleaning validation, FDA, FDA regulations, medical device, medical device cleaning, medical device testing, testing requirements, Validation requirements
Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers
AGAWAM, MASS. – January 12, 2009 – Two new white papers detailing sterility testing essentials are now available for free download from Microtest ( http://www.microtestlabs.com/). The white papers, one which is customized for medical device manufacturers and one which is specialized for pharmaceutical manufacturers, presents the general concepts and problems associated with sterility testing and reviews different testing methodologies. For medical device manufacturers, sterility testing of medical devices is required during the sterilization process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process. The need to provide adequate and reliable test data is an important quality control issue. False positive results and test failures can have significant impact on production schedules and device time-to market. Medical device manufacturers can download the white paper at: http://www.microtestlabs.com/sterilitypaper/sterility-paper.htm. The author of the white papers is Steven Richter, Ph.D., President and Scientific Founder of Microtest, a leading provider of medical device and pharmaceutical services for medical device designers and manufacturers. The firm recently expanded its facilities, resources, and technology, and with more than 15 years of experience, is a single-source manufacturing solution. For information on Microtest’s unique single-source solutions that minimize schedule disruptions and accelerate time to revenue visit Microtest on the Web: http://www.microtestlabs.com/ or toll-free: 1-800-631-1680. About Microtest Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680. # # # Labels: Compliance, FDA regulations, medical device, Microtest, pharmaceutical manufacturing, pharmaceutical testing, sterilization, white paper, whitepaper
White Paper Addresses FDA Approval Challenges Facing Combination Product Manufacturers
AGAWAM, MASS. – December 1, 2008 – Even as the combination products market continues to experience dramatic growth, the approval process facing manufacturers seeking to introduce new medical devices embedded with pharmaceutical or biologics components is expected to become even more challenging and complex.
“Given the convergence of technologies, combination product manufacturers – often either medical device or pharmaceutical companies “crossing over to the new market” – must ensure their products meet cGMP practices as well as pass muster with the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and The United States Pharmacopeia (USP),” said Steven Richter, Ph.D., President & Chief Scientific Officer of Microtest Laboratories, and a former FDA official.
“The combination products market is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements,” said Richter. “The process, already complex, is likely to become even more so,” he warned.
In fiscal 2007, the FDA received 333 original applications for combination products, a 42 percent increase over 2006. The FDA itself reports that combination product submissions “raise challenging regulatory, policy, and review management issues... (that) can impact the regulatory processes of all aspects of the product life cycle.”
In the free white paper, “Combination Products: Navigating Two FDA Quality Systems,” Richter provides a helpful overview of the challenges facing combination product manufacturers. Download the white paper at www.microtestlabs.com/combinationpaper.
“For manufacturers, the convergence of devices and drugs or biologics brings a host of new FDA testing guidelines, practices, and regulations unique to the development and production of combination products – and generally outside their original core competence in achieving regulatory approvals as either a medical device or pharmaceutical manufacturer,” he said.
In the white paper, Richter discusses: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations.
According to the FDA, some estimate the total global value of the drug-device combination products market will grow to $11.5 billion in 2010, up more than double from $5.4 billion in 2004.
Download the free white paper at: www.microtestlabs.com/combinationpaper. For more information, visit Microtest on the Web at www.microtestlabs.com, or call toll-free: 1-800-631-1680.
About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. # # #  Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/
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 Technorati tags: Microtest, FDA regulations, white paper, whitepaper, combo products, combination products
Labels: combination products, combo products, FDA regulations, Microtest, white paper, whitepaper
White Paper Advises Pharma Manufacturers on How to Select an Aseptic Fill/Finish Contractor, Avoid the Most Common Mistakes
AGAWAM, MASS. – For pharmaceutical manufacturers, the process of choosing a Contract Manufacturing Organization (CMO) can be a challenging task. The ramifications of making a poor decision can result in schedule delays, regulatory approval issues, and lost revenue. The informative white paper, “ Selecting An Aseptic/Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistake,” focuses specifically on the unique steps involved in selecting and working with an aseptic processing CMO to produce injectable Final Drug Product (FDP). Download it at: http://www.microtestlabs.com/asepticpaper. In addition to providing guidance on the selection process, the white paper also discusses common mistakes made by potential clients. These oversights – and their remedies – are sourced from a collective experience base that covers contract aseptic Fill/Finish (F/F) manufacturing, contract bulk drug manufacturing, and aseptic F/F outsourcing of bulk drug product. “The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations for Microtest Laboratories. Dobiecki’s experience, which spans 25 years in the manufacturing and quality control of pharmaceuticals, medical devices, and biologic products, includes the preparation of INDs, NDA/ANDAs, CMC sections, and Pre-Approval Inspections (PAI), as well as multiple U.S. and European Regulatory Inspections. In the white paper, Dobiecki: Details the nine key components of the RFP – The First Step (in the selection process) Discusses the finer points of Evaluating the Contractor’s Proposal Explains the two types of Site Visits and what should be included on the agenda Provides cautionary tips for making The Selection itself Warns of stumbling into making The Biggest Mistake which can derail a successful selection at any step of the process.
To download the white paper, free of charge, visit: http://www.microtestlabs.com/asepticpaper. About Microtest Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680. # # # Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/
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Technorati tags: Microtest, FDA regulations, white paper, whitepaper, combo products, combination products Labels: combination products, combo products, FDA regulations, Microtest, white paper, whitepaper
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