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    Use Sequential Sampling to Reduce Attribute Sampling Costs

    Ref: 26675 Wednesday February 28th, 2018 - Bethesda US

    Use Sequential Sampling

    Education: Dentistry, Medicine, Pharmacy, Paramedic

    Drug Products for Clinical Trials | FDA Approved Drugs List 2018

    Ref: 26563 03/01/2018 -> 03/02/2018 - Boston, MA US

    n January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&a

    Education: Medicine, Pharmacy, Veterinary

    Statistics for Non-Statisticians Course | Biostatistics Boston 2018

    Ref: 26564 03/01/2018 -> 03/02/2018 - Boston, MA US

    Course "Biostatistics for the Non-Statistician" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

    Education: Medicine, Pharmacy, Speech Therapy

    FDA regulations and the ICH GCP recommendations

    Ref: 26427 Tuesday March 06th, 2018 - Online

    Attending this Webinar is a good step toward learning the FDA processes and why the Sponsor's / CRO's Monitors are so important.

    Education: Pharmacy, Medicine

    Recent Updates of FDA 21 CFR 11 Add-On Inspections

    Ref: 26428 Wednesday March 07th, 2018 - Online

    This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11.

    Education: Medicine, Pharmacy

    Essentials of Dealing with Non-Conforming Material

    Ref: 26429 Thursday March 08th, 2018 - Online

    You'll learn about conducting failure investigations and requirements for correction and corrective action.

    Education: Medicine, Pharmacy

    How to Develop Predictive Warranty Using Paynter Charts

    Ref: 26430 Thursday March 08th, 2018 - Online

    Learn how Paynter Charts can be effectively utilized for predictive warranty management.

    Education: Medicine, Pharmacy, Management

    Regulatory Requirements Cleaning Validation | FDA Guidelines 2018

    Ref: 26565 03/08/2018 -> 03/09/2018 - Zurich, Switzerland US

    Course "Regulatory Requirements and Principles for Cleaning Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

    Education: Medicine, Pharmacy, Physiotherapy

    HIPAA Risk Assessment Checklist | HIPAA Compliance Training

    Ref: 26566 03/08/2018 -> 03/09/2018 - New Orleans, LA US

    The first presentation explains the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to

    Education: Medicine, Pharmacy, Veterinary

    FDA Process Analytical Method Validation

    Ref: 26431 Friday March 09th, 2018 - Online

    This webinar will discuss method validation requirements through the test method lifecycle: method development, the formal method validation and continued use of the method for routine testing.

    Education: Medicine, Pharmacy

    Medical Device Supplier Management Training | Switzerland

    Ref: 26567 03/12/2018 -> 03/13/2018 - Zurich, Switzerland US

    This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.

    Education: Medicine, Pharmacy, Speech Therapy

    How to Manage and Improve Human Reliability

    Ref: 26432 Tuesday March 13th, 2018 - Online

    This course offers practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

    Education: Pharmacy, Medicine, Public Health

    Eliminating Microbial Contamination in a Spiral Freezer

    Ref: 26433 Tuesday March 13th, 2018 - Online

    Food production facilities are facing greater scrutiny from both the public and the government to provide safe foods. There are about 48 million cases of foodborne illness annually. That's 1 in 6 Americans each year.

    Education: Medicine, Pharmacy

    Dietary Supplements CGMPS - 21 CFR 111 Compliance 2018

    Ref: 26434 Wednesday March 14th, 2018 - Online

    This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

    Education: Medicine, Pharmacy

    Write an Effective Standard Operating Procedure

    Ref: 26435 Wednesday March 14th, 2018 - Online

    This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

    Education: Medicine, Public Health, Pharmacy

    21 CFR Part 11 Compliance Checklist- FDA Software Validation

    Ref: 26568 03/14/2018 -> 03/15/2018 - Zurich, Switzerland US

    Course "21 CFR Part 11 compliance for software validation and SaaS/Cloud" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

    Education: Medicine, Pharmacy, Paramedic

    Supplier Management for Medical Device Manufacturers

    Ref: 26569 03/15/2018 -> 03/16/2018 - Frankfurt, Germany US

    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 device. Neither the FDA nor your notified body regulates yo

    Education: Medicine, Pharmacy, Paramedic

    IT Infrastructure Qualification Plan | Information Technology 2018

    Ref: 26570 03/15/2018 -> 03/16/2018 - Las Vegas, NV US

    Course "A Risk Based Approach To IT Infrastructure Qualification & Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

    Education: Medicine, Pharmacy, Paramedic

    Excel - Workbooks and FDA Device Regulations

    Ref: 26436 Wednesday March 21st, 2018 - Online

    Learn methods to recognize the use of Excel workbooks in production or the quality system.

    Education: Pharmacy, Medicine, Public Health

    GMP for Phase I Investigational Drug Products 2018

    Ref: 26437 Thursday March 22nd, 2018 - Online

    The necessary content of the IND will not be discussed in this webinar, but the specific GMPs for Phase I Investigational drugs will be understood by attendees.

    Education: Medicine, Pharmacy

    ISO 14971 Risk Management Training-IEC 62304 Risk Management

    Ref: 26571 03/27/2018 -> 03/28/2018 - Zurich, Switzerland US

    Course "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

    Education: Medicine, Pharmacy, Paramedic

    European Data Protection Regulation - 2018 Implementation

    Ref: 26438 Thursday March 29th, 2018 - Online

    Individuals in the EU may be unwilling to transfer personal data outside the EU if they are uncertain about the level of protection in other countries. How US businesses need to pay attention to this impact will be addressed.

    Education: Medicine, Public Health, Pharmacy

    FDA Guidelines for Pharmaceutical Industry | FDA Regulatory 2018

    Ref: 26572 03/29/2018 -> 03/30/2018 - Chicago, IL US

    Course "FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

    Education: Medicine, Pharmacy, Paramedic

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