Overview: There are mandatory, elective, and optional topics. These topics are outlined in the specific industry procedures. Mandatory topics are required and must be conducted for the minimum amount of time indicated. These topics are determined by OSHA and include: OSHA Orientation Work in Confined & Enclosed Spaces Walking/Working Surfaces; ladders, scaffolds, fall protection, etc. Personal Protective Equipment, all types Basic Electric...

Overview: Mental health care practitioners work in today's diverse, fast-changing, multidisciplinary health care environment. Nowhere but in mental health is there such diversity of clinicians who provide the same or similar services of counseling and therapy. A potential client has a wide choice of mental health providers from whom to choose. Yet each individual mental health profession has a unique education, training, and experience require...

Overview: The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts. Statistical Process Control Statistical methods for Design Verification Statistical methods for P...

Overview: Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment. The PL reflec...

Overview: This course will present the regulations and guidelines that apply to operations in quality control testing laboratories. In some cases these will not be specific regulations, but needs that, if met, will increase the efficiency or quality of activities in the laboratory. While it will not be possible to cover all of the subtle variations among regulatory regions, general internationally accepted practices that comply with GMP requir...

Overview: This course will present the regulations and guidelines that apply to operations in quality control testing laboratories. In some cases these will not be specific regulations, but needs that, if met, will increase the efficiency or quality of activities in the laboratory. While it will not be possible to cover all of the subtle variations among regulatory regions, general internationally accepted practices that comply with GMP requir...

Overview: The seminar will begin with an over view of data science and many the steps required for collecting, cleaning, organizing and deriving information out of data. The steps are common to all of the tools and will form the foundation for analyzing, comparing and utilizing the tools used in the remainder of the seminar: R, pandas and Deedle. Topics covered in the foundation are: Organizing information into data frames Mutating data frame...

We will consider the following: The Design Control requirements of the CGMPs, 21 CFR 820.30 The Design History File - documenting Product Design Control and its nine elements The Device Master Record and the Device History Record The EU's Medical Device Directive The "Essential Requirements"; and their documentation The remaining elements of a Technical File / Design Dossier Trends Two attendee projects Why should you attend? This seminar / wo...

Course "Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In...

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your devic...