Classified continued from p. 26 June 2013 Spray 45 etc.); emergency equipment; and lockout/tag out. OSHA’s ten most frequently cited standards are fall protection; hazard communication standard; scaffolding; respiratory protection; control of hazardous energy (lockout/tag out); powered industrial trucks; electrical, wiring methods, components and equipment; ladders; machines; and electrical systems design. After the walk around, the compliance officer holds a closing conference with the employer and employee representatives to discuss the findings. OSHA must issue a citation and proposed penalty within six months of the violation’s occurrence. Citations describe OSHA requirements allegedly violated, list any proposed penalties and give a deadline for correcting the alleged hazards. Violations are categorized as other-than-serious, serious, willful, repeated and failure to abate. Penalties may range up to $7,000 for each serious violation and up to $70,000 for each willful or repeated violation. Penalties may be reduced based on an employer’s good faith, inspection history, and size of business. For serious violations, OSHA may also reduce the proposed penalty based on the gravity of the alleged violation. No good faith adjustment will be made for alleged willful violations. When OSHA issues a citation to an employer, it also offers the employer an opportunity for an informal conference with the OSHA Area Director to discuss any information pertinent to the inspection. The agency and the employer may work out a settlement agreement to resolve the matter and to eliminate the hazard. Alternatively, employers have 15 working days after receipt of citations and proposed penalties to formally contest the alleged violations and/or penalties by sending a written notice to the Area Director. OSHA forwards the contest to the Occupational Safety & Health Review Commission for independent review. Citations, penalties and abatement dates that are not challenged by the employer or settled become a final order. Dolegiewitz stressed the importance of following industry standards and having all employees actively engaged in safety and health programs. Firms can learn from incident investigations conducted by U.S. Chemical Safety Board (www.csb.gov) FDA Paul Weiner of GxP associates presented How to Prepare for an FDA Inspection. A firm should prepare for a Food & Drug Administration (FDA) inspection when a new drug application is in it’s final state of review; a firm has received a Warning Letter and a re-inspection is due (usually within six months); the FDA warned they were coming; a firm and the FDA received a significant product complaint; or a firm informed the FDA of a product recall. Before the inspection, hold an FDA inspection training session with key management; advise department heads that a quality management team will inspect their areas to assure all suspect conditions are corrected. Decide who should greet the FDA investigator. Ask the investigator for their credentials and supervisor’s phone number to confirm this; why they are visiting; how long it will take; and if they are using a camera or recording device (explain your policy on this). Advise the inspector that s/he will need to be accompanied in the facility at all times, Weiner that a locked room will be provided for breaks, as well as for review of any company documents, and an escort provided for breaks. Determine to whom the investigator wishes to present the Notice of Inspection and other FDA documents, such as the receipt for samples, list of Inspectional Observations and any affidavits. Determine the firm’s policy on who can speak to the inspector and who will take notes. Determine a policy regarding taking duplicate photos, exhibits and samples given to the investigator, and whether the FDA will be charged for samples. Determine policy for revealing internal audits or financial information to the investigator. Finally, determine whether corrective actions should be taken while the inspection is in progress, what posture the firm should take at the close-out meeting regarding commitments to change and completion time-frames, and whether to request a close-out meeting at the end of each day of an on-going meeting. SPRAY Aerosol Equipment We are a dealer for new, used and rebuilt aerosol filling and packaging machinery. Contact us for your machinery requirements ranging from laboratory applications to high speed production lines. Call, Fax or E-mail for our current listings. Highlights: • Bag-On-Valve Equipment Indexing and Continuous Motion 20-240 CPM • KartridgPak Rotary Crimping, Undercup & TTV gassing machines, 6-12 Head TTV Gasser Machine “Ready to Ship” • Indexing Lines Available 20-120 CPM • Haumiller 3200 Series Tipper Beardsworth Group, Inc is an active buyer for your used/surplus Aerosol Lines, Individual Machines and Parts. Visit us on the web: beardsworthgroup.com Beardsworth Group, Inc. 40 East Farm Street Waterbury, CT 06704 Phone (203) 263-3811 Fax (203) 759-0170 bgisales@beardsworthgroup.com SENIOR R & D CHEMIST WANTED A.J. Corp, is a manufacturer of quality aerosols, liquid and specialty products serving the automotive and industrial industry for over 50 years. A.J. Corp has an excellent opportunity for a Senior Research & Development Chemist/Manager who will be responsible for directing the activities of other Lab Technicians on multiple projects including new product development. In this key role the individual will manage the Research and Development (R&D) activities as well as quality assurance and regulatory activities carried out by the company. This person will also be a critical link in technical communications and support both within the company and with outside supplier and customer to determine and verify technical aspects of the company’s chemical projects. REQUIRED EXPERIENCE • 10 years in Product Development of similar products (Preferably aerosols/chemicals) • 10 years in Personnel Management with demonstrated leadership skills in mentoring and supervision of technical staff • Strength in chemical fundamentals and technical project management • Experience in test development and analysis of test results • Basic computer skills including Microsoft Office products If you are not local to the Central United States/Midwest Area, we do provide relocation benefits for qualified candidates. American Jetway Corp 34136 Myrtle St Wayne, MI 48184 Phone (734)721-5930 Fax (734) 721-7829
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