Why should you Attend:
FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. They are certain to impact your regulatory risk profile. How will you prepare for software quality, software validation and 21 CFR part 11 planning?

Extensive use of automated manufacturing, laboratory, QA, QC, complaints, CAPA, Adverse Events systems puts companies at risk. FDA field staff has been trained on software validation and 21 CFR Part 11 inspection and enforcement. Many companies have fallen behind in their software validation practices. Now is the time for forward planning in this crucial area. This executive planning session discusses the key elements on which to focus. The attendee should leave this strategic planning session confident in knowing how FDA will approach software validation enforcement and how to prevent needless inspections, as well as how to satisfy an FDA inspector.

Areas Covered in the seminar:

- Outline of new FDA enforcement approach.
- When will FDA issue a Warning Letter for software validation.
- What happens after a Warning Letter is issued under the new enforcement system?
- How planning can help now and in the future.
- The pivotal role of the Director of Software Quality / Software Validation.
- How your people can really help or hurt you.
- Effective software quality / validation structure.

This Medical device training will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with the new standards.

Description
Why Should You Attend:

Many regulated companies have not brought their old products up to the new FDA standards and are not in compliance. This webinar defines the criteria to be used for medical products design history file remediation.

For example companies should be compliant to 14971:2007. Design History Files need to be adjusted to meet the new standards. The FDA expects risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product. Each product needs to have a gap analysis to determine obsolescence or validate. It should also describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.

In this webinar, we will discuss practical steps you can follow to bring your product design history files up to date with the new standards.

Areas Covered in the Seminar:

Multi-functional team approach/responsibility.
Set procedures and template to complete remediation for design history file of old products to meet the new standards.
Gap analysis.
Gathering of data to build the design history files.
Risk procedure.
Risk assessment for prioritizing remediation.
Traceability matrix.
Validations.
Dealing with the FDA.
Check list.
Who Will Benefit:

This webinar will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with the new standards. The employees who will benefit include:

End-users responsible for design control and technical files that need to be updated to the new standards
R&D and product development engineers and managers
Remediation teams
QA, Regulatory Affairs and team members who contribute to design history or technical files
Validation specialists
Consultants
Corporate auditors
Instructor Profile:

Rob Braido, is the founder and principle of Visionary Consulting LLC, a consulting firm that specializes in gap analysis and due diligence for management evaluation of product design and emerging technology acquisition. Visionary Consulting also specializes in the project management of equipment and product transfers in the medical device and surgical instrument market.

Mr. Braido develops cutting edge prototype/product development business models for pull through business for increased profit and growth. Rob is a frequent conference speaker and has published many articles on Medical Product Development and Leadership.

Why Should You Attend:

Drug Product must maintain its identity, strength, quality and purity throughout its expiration. Physical, chemical and biological data are influenced by various environmental factors such as temperature, humidity and light. In current manufacturing environment, products can be shipped and distributed across different climatic zones. Seasonal changes as well as types of transportation can greatly affect the supply chain of the products.

This webinar will outline stability studies to support shipping and distribution of drug products. Upon completion of this session, attendees will learn key factors that would affect the shipping and distribution of drug products. you will understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping condition in order to maintain quality of the drug product through expiry.

Areas Covered in the Seminar:

Goal of stability studies.
Warning letters and observations on shipping and distribution practices.
Short term excursion study.
Thermal cycling study.
Analytical testing for these studies.

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In recent months most discussions around Lean transformations in
Contact Centres have understandably evolved around managerial and
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