Due to cost advantages from producing overseas, revenue opportunities from foreign sales and the potential to exploit new technology, tapping international markets holds the greatest potential for growth.
The optimal approach for entering or expanding into foreign markets depends on the characteristics and objectives of the particular firm. Proven strategies include exporting, licensing, joint ventures, and establishing an overseas facility.
How a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working.
Why should you Attend:
Your implementation time should be short and need smart ideas to
reach the right level to pass the MDSAP - Audit by your audit organization.
Areas Covered in the Session:
Which Companies must have MDSAP?
Which Companies should have MDSAP?
Which Companies should postpone MDSAP?
What are the requirements of MDSAP?
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.
Areas Covered in the Session:
What 21 CFR Part 11 means today
Purpose of Part 11
What does Part 11 mean?
Who Will Benefit:
GMP, GCP, GLP, Regulatory Professionals
Managers and Directors
Software Vendors, Hosting Providers
In this interactive session author will discuss about the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Why should you Attend:
The new import entry filing requirements became effective in 2016
and are posing problems for user. Failure to provide the correct information creates costly delays and, in some cases, the frustrating task of contacting the FDA to resolve the problem.
This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites.
This will enable you to meet the new international GCP standard to ensure regulatory compliance and the acceptance of clinical trial data by the regulatory authorities internationally.
HIPAA compliance takes time. But both goals can be accomplished - in fact, a good compliance program can make you even more competitive because compliance helps protect and grow your business and sets you apart from your competitors. For example, knowing how to use social media and electronic communications within HIPAA rules is key to staying competitive.
In this webinar speaker will define the steps necessary to prepare for an FDA inspection and discuss details surrounding the management of inspections from announcement to close out meeting.
Why should you Attend:
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates.
The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate.
Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.
In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle:
Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.
This session will cover various types of essential documentation, subject specific and non-subject specific, for clinical trials involving drugs, biologics and medical devices trials.
To provide current concepts in seasonal influenza vaccines for the 2018-2019 season
To assess how strain matching and efficacy are linked.
What vaccines are available this season in USA and ROW.
Non egg adapted vaccines.
Trivalent and quadrivalent vaccines.
This years vaccine composition and WHO recommended strains.
Towards a universal Influenza vaccine.
This webinar is specifically designed for sponsoring biopharma and device companies who are outsourcing.It will help you get to grips with effective Vendors (including CRO,CMO, and other vendors) management used in the biopharma and device industries and your responsibilities as the sponsor.
It will also show you how to clarify roles and responsibilities, focus on oversight preparation and planning including understanding insight vendor performance measurement including metrics and key performance indicators.
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.
Why should you Attend: CAPA is the cornerstone of quality improvement and it depends on an effective root cause analysis. Conducting an effective root cause analysis (RCA) can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement.
Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.
The CMS Open Payments Rule (sometimes referred to as the "Physician Payment Sunshine Act") was born out of the Affordable Care Act. This presentation will walk you through the requirements under the regulation and discuss the logistics and strategies for compliance.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Compliance-with-the-CMS-Open-Payments-Rule-Sunshine-Act-504674/AUGUST-2018-ES-TRAININGREGISTRY
This webinar will provide the regulatory requirements (US) of 21 CFR Section 820.50 (Purchasing Control) for the Medical Device industry and provide you with examples. It will furnish details on what should your Purchasing/Supplier Control management system address.
Supply chain activities (including, the increase in outsourcing materials, components , manufacturing and services) have become more complex to manufacturers and oversight has become more challenging and complicated. Manufacturers are required to manage carefully their entire supply chain. Purchasing and Supplier Control deficiencies have ranked in the top 10 deficiencies related to warning letters.
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
The statistical methods discussed during the webinar include the following:
Process Control Charts
Process Capability Indices
Confidence / Reliability Calculations
MTBF Studies ("Mean Time Between Failures" of electronic equipment)
QC Sampling Plans