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McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

NIH Clinical Center: Pharmacy Services

Practicing Laboratory Safety in the Workplace. Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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Duration: Min. This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies.

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For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips. There are hundreds of RAC testing centers available worldwide. Find an upcoming exam at a location near you. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time. The US Food and Drug Administration FDA has released data on the observations it makes during inspections of pharmaceutical facilities, indicating the most common issues faced by pharmaceutical companies.

In its most recent report, FY Inspectional Observation Summaries , FDA said it issued Form s—forms indicating areas of noncompliance at a facility—to pharmaceutical companies in fiscal year Lock Members Only close arrow-right cart search google-plus facebook twitter youtube flickr linkedin calendar user menu menu-close print share circle-down help briefcase latest recon star word-bubble news.

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    Fundamentals of US Regulatory Affairs, 11th Edition For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips. Story Thumbnail.

    Barbara Unger

    Regulatory Focus newsletters All the biggest regulatory news and happenings. The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity.

    There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

    Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.