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• Discussion of the FDA’s draft guidance for industry and FDA staff, “Processing/ Preprocessing Medical Devices in Healthcare Settings”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.

Outsourcing to a Contract Testing Laboratory is Focus of 2013 AAPS Expo Workshop

AGAWAM, MASS. – Nov. 5, 2013 – The strategies and timing of outsourcing pharmaceutical development processes to a contract testing laboratory will be the focus of a mini-workshop at the 2013 AAPS Annual Meeting and Exposition on Nov. 12, 2013.

“Outsourcing to a contract testing laboratory can save pharmaceutical manufacturers both time and money in drug development and commercialization. But knowing the appropriate time and place to outsource can mean the difference between success and failure,” said Shawn Sherry of Microtest Laboratories.

At the mini-workshop, titled “Outsourcing to a Contract Testing Laboratory,” Sherry will overview:

• The benefits of using turnkey contract laboratory services
• How to establish a smooth working relationship with your laboratory
• The importance of the auditing process
• Quality system, timeline, and pricing factors
• How Microtest Laboratories can help

The mini-workshop will be presented Nov. 12^th from 2:00 p.m. to 2:15 p.m. in the Microtest Laboratories booth, #1325, at the AAPS 2013 Annual Exposition.

Shawn Sherry, Account Development Manager at Microtest Laboratories Inc., has over 11 years’ experience in regulatory microbiology and contract laboratory operations. Sherry holds a BS degree in microbiology and is a nationally registered microbiologist. His experience ranges from compendia testing requirements to aseptic manufacturing, with emphasis on disinfectant qualifications, clean room testing, product testing, and water system validations. He is the co-author of the whitepaper, “Disinfectant Qualifications: Insight and Perspective,” available at http://www.microtestlabs.com/disinfectant-qualifications.

Microtest Laboratories will exhibit in booth #1325 throughout the 2013 AAPS Annual Meeting and Exposition. Microtest Labs is a leader in pharmaceutical contract manufacturing as well as microbiological, analytical, and cleanroom testing services. The company services the pharmaceutical, medical device, and biotechnology industries. Based in Agawam, Mass., Microtest's testing facilities are ISO 9001 and ISO 17025 certified, FDA regulated, and meet all GLP/GMP standards. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.