Bob
Yeoman and Ron Ball
B&R Compliance
PO Box 20603
Lehigh Valley, Pa 18002
Phone: (610) 868-7183
Fax: (610) 868-7185
bob.yeoman@brcompliance.com ron.ball@brcompliance.com
www.brcompliance.com
Bob's background blends an engineering background together with a career in safety, quality, and regulatory affairs. During his 25-year career in the gases industry, he has been intimately involved in industry activities, having served as chairperson of the CGA Safety & Environmental Activities (SEA) Council, and co-chairperson of the GAWDA safety committee. His opinion and insights into industry compliance are regular features in publications read throughout the industrial and medical gas industry, and at industry sponsored conferences and meetings. FDA recognizes Bob as the voice of the independent gases and welding distributor on medical gas compliance issues and he represents GAWDA at the CGA Medical Gas Regulatory and Policy task force (MGRP). Prior to co-founding B&R Compliance Associates Bob was vice president of regulatory affairs for a major industrial and medical gas producer.
Ron has over 35 years of experience in pharmaceutical manufacturing, including an extensive career in Medical Gas Operations working closely with Gases and Welding distributors to identify and implement FDA Compliance solutions. His background includes quality systems development for operating procedures, training, analytical methods, validation, and auditing. The gases industry and FDA recognize Ron as one of the leading experts on compliance issues today. A number of Ron's training programs have received national recognition for excellence, and he has been a featured speaker on regulatory issues at numerous industry-sponsored events. Prior to co-founding B&R Compliance Associates Ron was director of Compliance for a major industrial and medical gas manufacturer. Our experience encompasses ASU, Helium, Nitrous Oxide, and CO2 production, cryogenic distribution and storage systems, high pressure and liquid cylinder filling and distribution, and home health care operations. Our expertise includes engineering, operations and regulatory compliance know-how. B&R Associates are available to provide a wide range of compliance programs and services for FDA and Medical Gas GMP compliance including SOP development, training, and auditing.
New Announcements
10/11/06 - “7 Most Common cGMP Violations”
7/6/06 - The Cost Estimates of Compliance with the Proposed Rule
7/5/06 - After three months of diligent effort, GAWDA and CGA have developed and refined a detailed set of comments in response to FDA’s proposed new regulations for medical gas mix-ups. This 22 page GAWDA / CGA joint comments letter can be viewed here.
May 18, 2006 - GADWA FDA Compliance Update Teleconference Audio
GADWA FDA Compliance Update Teleconference PowerPoint presentation
April 19, 2006 - FDA proposes new regulations on Medical Gas Container and Closures
11/3/05- FDA Update Web Conference featuring Bob Yeoman & Ron Ball
To listen to Recording right click and choose save target as Gases & Welding 11-03-05 196302.mp3
In order to listen to this recording you will need an mp3 player.
GAWDA recomends using either iTunes or WinAmp.
Mac or Windows: iTunes
Windows: Winamp
Download Presentation Slides
11/2/2005 AHCA Eases Oxygen Refill Requirements
3-15-05 USP postpones planned revisions to the medical gas monographs.
3/9/05 - GAWDA Files Comments with FDA and USP/NF
GAWDA and CGA have filed comments with FDA and USP / NF on the recent changes to the medical gas monographs. GAWDA is working hard on behalf of our members to achieve an acceptable resolution to this issue. Further information will be provided as it is available. For more information on the proposed USP changes contact the GAWDA medical gases consultants – B&R Compliance Associates, or join over 70 other GAWDA members at the Compliance training seminar in Indianapolis, IN March 30th.
3/1/05 - GAWDA and B&R Compliance announce revisions to Medical Gas SOP Manual
2/11/05 - USP / NF implement major changes in the testing requirements for Nitrogen NF and Nitrous Oxide USP.
3/2/04 - FDA has released its “Final Rule” document on “Bar Code Label Requirements for Human Drug Products and Biological Products”. Medical Gases have been specifically exempted from the requirement.
12/18/03 GAWDA and CGA Settled Pressure Regulatory Initiative
GAWDA and CGA met with senior DOT officials last month to propose an initiative to lead to a resolution of the not uncommon practice, in violation of DOT rules, to purposely overfill cylinders with compressed gases in order to assure that the cylinder is filled at least to the cylinder's stated service pressure at 70ºF. A joint letter from CGA and GAWDA to the membership is attached, and explains the initiative in detail. Pending results of the initiative, DOT will exercise "broad enforcement discretion." However, "DOT requested that CGA and GAWDA notify their members that overfilling compressed gas cylinders will not be allowed and that companies should review their filling procedures to ensure that they reflect DOT requirements, for example 49 CFR 173.301a and 173.302a." Click here for the explanatory letter.
10/23/03 CGA/GAWDA Comments Regarding Draft FDA Guidance for Industry on the cGMP for Medical Gases
10/20/03 - FDA has released the procedures for registration of food and food ingredient production facilities. GAWDA members can click on the following link and follow the instructions to register their firm. To determine if your firm is required to register download and review the Bioterrorism presentation teleconference slides. http://www.cfsan.fda.gov/~furls/ovffreg.html
9/26/03 - FDA has released an updated version of their guidance document for field inspections of medical gas facilities. While the document does not include any references to the new, draft, guidance document it does provide general instructions on what areas field inspectors should review when at a medical gas manufacturing facility. Members with questions about FDA inspections, or would like some assistance in preparing for an FDA inspections should contact B&R Compliance Associates LLC.
9/4/03 - FDA issues Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application
8/19/03 - FDA introduces new proposed regulations in response to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. These regulations will impact gas producers and distributors that sell to the food and beverage industry. You can read and download the full text of the regulation from the above link. CLICK HERE for recent teleconference handouts.
GAWDA MONTHLY PUBLICATIONS
Safety Topics
Safety Tips
Compliance Bulletins
Compliance Calendar
Medical Gas Issues
Medical Gas Directory
Recent Articles and Information
Archived Safety Documents, Regulations, etc
FDA Annual Registration & Drug Product Listing Requirements(12/04)
Nitrogen Open Top Dewar Filling for Medical Us(11/04)
Alert: Cylinder Fill Plant Validation Activities(10/04)
Alert: Abusive Use of Nitrous Oxide(9/04)
Summary Progress Report - Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach - Questions and Answers
Guidance For Industry Part 11, Electronic Records
Medical Gas Mix-Ups Display Information GAWDA is working with the US. Food and Drug Administration to help communicate the importance of training and following safe practices with regard to medical gases. Download images to create posters and stickers to remind people working with medical gases of the importance of following established safe practices. |
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