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Drug Substances and Drug Products - Specifications

Ref: 26778 Wednesday May 23rd, 2018 - Online

Learn requirements for changing specifiations through the lifestyle of the product.

Education: Medicine, Pharmacy, Bio-Technologies, National Health, Management

A Risk Based Approach to IT Infrastructure Seminar 2018

Ref: 26928 05/24/2018 -> 05/25/2018 - Minneapolis, MN US

  Course "A Risk Based Approach To IT Infrastructure & Cloud Qualification, Compliance & Control" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: GxP Regulated companies are dependent on ...

Education: Pharmacy, Medicine

ICH Q10 – A Focal Point for Contemporary Compliance

Ref: 27246 Thursday May 24th, 2018 - Bethesda US

Objectives The term Quality System began appearing in FDA publications and guidances about the turn of the century. In 2008 the FDA and ICH released ICH Q10, The Pharmaceutical Quality System and many of the FDA publications are based on the Quality System philosophy. Therefore, it is ...

Education: Dentistry, Medicine

Learning Management Systems | LMS Seminar 2018

Ref: 27093 06/04/2018 -> 06/05/2018 - Seattle US

Course "Learning Management Systems (LMS)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will describe the development of job position curricula in the pharmaceutical industry using a ...

Education: Medicine, Pharmacy

Essential Training for IRB Members and Staff

Ref: 26943 Tuesday June 05th, 2018 - Online

This webinar serves will provide substantive training of the criteria for IRB approval for new IRB
members/staff who have less than three years of experience.

Education: Pharmacy, Bio-Technologies, Management, National Health

Label Promotion of Drugs and Medical Devices 2018

Ref: 26944 Tuesday June 05th, 2018 - Online

This session sets the context for the off-label promotion of medical products starting
with early history and moving to the most recent history of FDA's decision on guidance documents.

Education: Bio-Technologies, General medicine, Management, National Health

HIPAA and the Business Associate | Savannah Seminar 2018

Ref: 27098 Tuesday June 05th, 2018 - Savannah US

Overview: This one-day seminar will be addressing how a Business Associate needs to comply with HIPAA and when it applies. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, as there is so much misleading information regarding the do's ...

Education: Pharmacy, Medicine

What You Need to Do to Prepare for a Successful Inspection?

Ref: 27092 06/06/2018 -> 06/07/2018 - Virginia Beach US

Course "How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full ...

Education: Medicine, Pharmacy

Why Organizations need to use CAPA, What is its Purpose?

Ref: 26945 Thursday June 07th, 2018 - Online

Learn how FDA investigates CAPA in organizations, and be prepared for an audit in your organization.

Education: Medicine, Bio-Technologies, Management, National Health

How to Conduct Effective Close out Meetings

Ref: 26946 Thursday June 07th, 2018 - Online

This webinar is designed to provide the participants a working knowledge of supplier audits.

Education: Medicine, Bio-Technologies, National Health, Management, Pharmacy

Managing Your FDA Inspection: Before, During and After

Ref: 27094 06/07/2018 -> 06/08/2018 - Washington US

Course "Managing Your FDA Inspection: Before, During and After" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's inspection program follows well-established procedures and conducts the inspections ...

Education: Medicine, Pharmacy

Water System Investigation "How-To's" and Example Case Studies

Ref: 27100 06/07/2018 -> 06/08/2018 - Washington US

Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this ...

Education: Pharmacy, Medicine

What Sponsors Expect and How to Meet their Expectations

Ref: 26947 Friday June 08th, 2018 - Online

How to Meet their Expectations, Also learn Managing and avoiding common pitfalls with CROs/Vendors.

Education: Medicine, General medicine, Internal medicine, Management, National Health

Which data and systems are subject to 21 CFR Part 11

Ref: 26948 Friday June 08th, 2018 - Online

This webinar demystifies Part 11, and get you on the right track for using electronic records
and signatures to greatly increase productivity.

Education: Medicine, Bio-Technologies, General medicine, Management, National Health

How an Organization can remain Compliant with these Regulations

Ref: 26949 Monday June 11th, 2018 - Online

How an organization can remain compliant with these regulations in their day-to-day operations.

Education: Medicine, Bio-Technologies, General medicine, Management, National Health, Pharmacy, For the general public

Medical Device Software: An Incremental Approach to Risk and Quality Management

Ref: 27095 06/11/2018 -> 06/12/2018 - Ca US

Course "Medical Device Software: An Incremental Approach to Risk and Quality Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.   Overview: Engineers are dedicated to making things work, so a ...

Education: Medicine, Pharmacy

What are the principles of HEPA filtration?

Ref: 26950 Tuesday June 12th, 2018 - Online

This webinar first details and explains the various US and international regulatory requirements
for various clean room classifications.

Education: Medicine, Computer science, General medicine, Management, National Health, Pharmacy, For the general public

HIPAA compliance from Start to Compliance 2018

Ref: 27091 06/13/2018 -> 06/14/2018 - Salt Lake City US

Course "HIPAA Compliance 2018" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.   Overview: This two day seminar takes the participants through HIPAA compliance from start to compliance. The first ...

Education: Medicine, Pharmacy

Complaint and Recall Management Seminar 2018

Ref: 27090 06/14/2018 -> 06/15/2018 - Boston, MA US

Course "Complaint and Recall Management: A Compliant, Lean Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.   Overview: Complaint handling is likely one of the more cross-functional parts of ...

Education: Medicine, Pharmacy

Project Management for Non-Project Managers | Seminar 2018

Ref: 27096 06/14/2018 -> 06/15/2018 - Boston, MA US

Course "Project Management for Non-Project Managers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This two-day seminar will begin by laying the foundation for the subject by first defining what a ...

Education: Medicine, Pharmacy

SOP Development and Implementation for the FDA-Regulated Industry

Ref: 27099 06/14/2018 -> 06/15/2018 - Boston, MA US

Course "SOP Development and Implementation for the FDA-Regulated Industry " 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 will explore what SOPs are, what they are used for, ...

Education: Hospital, Pharmacy

Preparation of FDA Submissions and Communicating with the FDA | Seminar 2018

Ref: 27102 06/20/2018 -> 06/21/2018 - Opfikon-Glattbrugg CH

Course "Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Why ...

Education: Medicine, Pharmacy

21 CFR Part 11 Guidance for Electronic Records - 2018

Ref: 26779 Thursday June 21st, 2018 - Online

ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

Education: Pharmacy, Bio-Technologies, Computer science, Management

Controls Over Transportation of Fresh Organic Foods

Ref: 26951 Tuesday June 26th, 2018 - Online

The US Department of Agriculture reports punishable fines up to $11,000 and encourages reporting
complaints.

Education: Medicine, Computer science, General medicine, Management, National Health, For the general public

New EU Medical Device Regulation | Updated Regulation 2018

Ref: 27089 06/27/2018 -> 06/28/2018 - Chicago, IL US

Course "The New EU Medical Device regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.   Overview: Regulation proposals of the European Commission Background In 2012, the Commission adopted a ...

Education: Medicine, Pharmacy

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