Pharmacy meetings - Pharmacy educations

How to properly investigate OOS/OOT Results

Ref: 25630 Friday July 28th, 2017 - New York City ^US

This OOS guidance webinar will review the regulatory requirements for investigating an OOS Investigation. Register now or call +1-844-746-4244

Cyber Attacks, Beyond Disaster Recovery - 2017

Ref: 25586 Tuesday August 01st, 2017 - Online

Overview: Cyber-attacks and breaches dominate the media and are a significant focus  of the government. Businesses and financial institutions are faced with the  grim reality that a cyber-attack is inevitable. It's not a matter of if an attack  will occur, only ...

Change Control Best Practices - Avoiding Unintended Consequences of Changes

Ref: 23025 08/03/2017 -> 08/04/2017 - Irvine ^US

Course Description: With FDA citing inadequate change control constantly in its 483s and Warning Letters, the prerequisite to ensure that changes are accurately described, justified, assessed for risk, implemented, and documented has come to the fore. Changes must also be prospectively reviewed ...

HIPAA Privacy and Security Time to get Serious 2017

Ref: 25610 08/03/2017 -> 08/04/2017 - Raleigh, NC ^US

Practice Managers
Compliance Officers, and any Business Associates Privy to Private Health Information and Under the Auspices of this Law.

Biosimilar from Development to Registration 2017

Ref: 25611 08/03/2017 -> 08/04/2017 - Raleigh, NC ^US

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access.

Effective Supplier Qualification Program - 2017

Ref: 25587 Thursday August 03rd, 2017 - Online

Overview: FDA considers the supplier as an extension of your operation. You are liable  for supplier’s conduct. FDA will deal with your company in case of product  failure, especially as related to end user or patient safety concerns.    Areas Covered in the ...

FDA Legal Writing Skills for Regulatory & Quality Submissions 2017

Ref: 25609 08/03/2017 -> 08/04/2017 - Raleigh, NC ^US

Regulatory Affairs professionals
Quality Assurance professionals
Marketing professionals
Scientific and Engineering / Product Development ManagersConsultants to any regulated industry

Statistical Methods A Visual Approach 2017

Ref: 25612 08/03/2017 -> 08/04/2017 - Raleigh, NC ^US

An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present

UAA 2017 - Urological Association of Asia Congress

Ref: 24501 08/04/2017 -> 08/06/2017 - Hong Kong ^HK

The 15th Annual Congress of the Urological Association of Asia (UAA 2017) will highlight the latest developments in various urological areas, including uro-oncology, voiding dysfunction and stone management. The main objective of the conference is to create a state of the art scientific program ...

Achieving Compliance Excellence - 2017

Ref: 25588 Friday August 04th, 2017 - Online

Overview: We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization.    Why should you Attend: Because as much as we try, most regulated industries don't have a set approach for ...

Validation Program to a Building from Top to Bottom - 2017

Ref: 25589 Friday August 04th, 2017 - Online

Overview: Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program.    Why you should attend: How PLC-based systems or laboratory ...

FDA Inspection and Respond to 483 & How to Prepare them - 2017

Ref: 25590 Tuesday August 08th, 2017 - Online

Overview: In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection.   Why should you Attend:  FDA is required to conduct an ...

CAPA within a Device Quality System - 2017

Ref: 25591 Wednesday August 09th, 2017 - Online

Overview: You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you.   Why should you Attend: Corrective and Preventive Action (CAPA) is the cornerstone of a strong Quality ...

Environmental Monitoring Program at FDA Regulations - 2017

Ref: 25592 Thursday August 10th, 2017 - Online

Overview:   Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring.   Why should you Attend: The cost of ...

Documenting Software for FDA Submissions 2017

Ref: 25613 08/10/2017 -> 08/11/2017 - District Of Columbia ^US

When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for

Controlling Hazards in Spices : Basic Supply Chain Food Safety Control Requirements

Ref: 25673 Tuesday August 15th, 2017 - New York City ^US

This FDA compliance training will cover basic microbial reduction techniques and other basic spice handling food safety considerations. Register now!

ISO 14971 Hazard Analysis at Medical Device - 2017

Ref: 25594 Thursday August 17th, 2017 - Online

Overview:   The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.   Why should you Attend:  FDA expects that as part of a ...

HIPAA Compliance Requirements for Business Associates 2017

Ref: 25614 08/17/2017 -> 08/18/2017 - Cincinnati, OH ^US

Compliance Officer
HIPAA Privacy Officer
HIPAA Security Officer
IT StaffOffice ManagersHealth Application ManagersCompanies providing healthcare data analyticsInformation Systems ManagerChief Information OfficerGeneral Counsel/lawyerPractice Management ConsultantsAny Business Associates that

The Challenges of an Effective Change Control Program 2017

Ref: 25615 08/17/2017 -> 08/18/2017 - San Diego ^US

An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents. To control this process, one must have both a defined change control procedure that outlin

Quality Management System ISO 13485- 2017

Ref: 25616 08/17/2017 -> 08/18/2017 - 60176 ^US

The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but t

New FDA FSMA Rules on the Sanitary Transportation 2017

Ref: 25617 08/17/2017 -> 08/18/2017 - Raleigh, NC ^US

Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act

IPF Summit

Ref: 25508 08/21/2017 -> 08/23/2017 - Boston ^US

Transforming Discovery and Translational Fibrosis Research into Disease Modifying IPF Therapeutics.

HIPAA Breach Notification Rule - What you must do to comply

Ref: 25730 Tuesday August 22nd, 2017 - New York City ^US

This webinar will explain what Covered Entities & Business Associates must do to comply with the Breach Notification Rule. To preserve your organization's reputation and limit its financial loss you must be prepared to assess a suspected Breach and to respond properly.

Letters of Credit are issued under the Customs and Practice 2017

Ref: 25595 Tuesday August 22nd, 2017 - Online

Overview: Letters of Credit are the primary instruments for assuring payment of goods sold internationally. Letters of Credit are issued under the Uniform Customs and Practice standard and can be negotiated by over 30,000 banks worldwide.    Why should you Attend: With financing ...

Root Cause Analysis and CAPA using 8-D Problem Solving Method 2017

Ref: 25618 08/24/2017 -> 08/25/2017 - Minneapolis, MN ^US

Errors and defects are a problem in virtually every industry. The goal of defect-free/error-free product or service delivery is the aim of every company. However, in order to eliminate defects or errors permanently, you must use a disciplined approach in order to ensure that the problem does not rec