Current Regulatory Expectations Affecting the Validation of Reusable Medical Devices is Subject of Dec. 4th Seminar in Boston

AGAWAM, MASS. — Nov. 12, 2013 — A half-day seminar focusing on current regulatory expectations in the validation of reusable medical devices is the subject of a seminar set for Dec. 4^th in Waltham, Mass., near Boston.

The validation of reusable medical devices is at the forefront of the FDA’s efforts to ensure patient safety. Requirements for the cleaning, disinfection, and sterilization of reusable devices are constantly changing. The situation challenges manufacturers both in terms of deciding which testing methods to employ as well as the planning of end points.

The seminar will provide attendees with the knowledge they need to know about current regulatory expectations so they may better prepare their submissions for FDA acceptance — and avoid the time-consuming and costly requirements of additional testing.

Seminar topics will include:

• Discussion of the FDA’s draft guidance for industry and FDA staff, “Processing/ Preprocessing Medical Devices in Healthcare Settings”
• Methods used for the cleaning and validation of reusable devices
•  Methods for the disinfection of reusable devices
• Methods for the sterilization of reusable devices
• Testing requirements
• Detailed discussion of endpoints for cleaning validation

The seminar will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, on Wednesday, Dec. 4, 2013, from 9 a.m. to 1 p.m. at the Conference Center at Waltham Woods in Waltham, Mass., just outside Boston. Registration is at 9 a.m. A continental breakfast, break refreshments, and a luncheon are included.

To register, visit the Validation of Reusable Medical Devices seminar event webpage or contact Julie Adamski 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com. Advance registration is $149.

“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 31^st, 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.

To register, download the form at http://www.microtestlabs.com. Or, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. The registration fee is $149.

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.

Clean Room Environmental Best Practices for Medical Device & Pharmaceutical Manufacturers are Focus of Boston Seminar on June 6

AGAWAM, MASS. – May 30, 2012 – Sterile manufacturing environments at medical device and pharmaceutical companies require effective cleaning and disinfection programs to maintain aseptic conditions and prevent microbial contamination. To help, laboratory testing experts will present "Clean Room Environmental Best Practices," a special seminar in Boston on Wednesday, June 6, 2012.

The seminar is designed for all professionals responsible for building, validating, and maintaining controlled environments in the medical device and pharmaceutical industries. The program will include technical presentations on:

• Best practices for qualifying and maintaining clean room facilities

• "The people factor" in terms of containment control

• Qualifying and evaluating clean room disinfectants

• Difficult challenges: Practical advice and solutions

Opportunities for questions and continuing interaction will be encouraged.

"Clean Room Environmental Best Practices" is scheduled for 10 a.m. to 2 p.m. on Wednesday, June 6, 2012, at the MIT Endicott House, 80 Haven Street, Dedham, Massachusetts — located just minutes from Boston. The cost is $149. Breakfast, lunch, and networking opportunities are included.

The seminar is sponsored by Microtest Laboratories, a Massachusetts-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest's environmental sciences group helps its clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

For more information, contact Julie Adamski, toll-free, at 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that 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. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

Clean Room Environment Seminar - Presented by Microtest Laboratories

Save the Date — June 6, 2012

Microtest Labs invites you to its Clean Room Environment Seminar, at the MIT Endicott House in Dedham, Massachusetts.

Sterile manufacturing environments require effective cleaning and disinfection programs to maintain aseptic conditions and prevent microbial contamination. This seminar will focus on best practices for qualifying and maintaining clean room facilities as well as understanding the qualification and evaluation of disinfectants used in this environment.

The presentations will be given by technical experts and will include practical advice and solutions to some of the industry’s most difficult challenges.

Save June 6, 2012, 10:00 a.m. to 2:00 p.m. to attend this complementary seminar that will help you build and maintain a controlled environment that is validated and ready to go! Lunch and a networking reception will be included.

Complete conference agenda and details will be sent to you in the coming weeks. For more information or to RSVP, contact 1.800.631.1680 Ext 192 or jadamski@microtestlabs.com.