Event Calendar

08 December 2016

THE AESTHETIC AND FUNCTIONAL REHABILITATION: TRADITION vs. INNOVATION

(73889)
  • THE AESTHETIC AND FUNCTIONAL REHABILITATION: TRADITION vs. INNOVATION
    THE AESTHETIC AND FUNCTIONAL REHABILITATION: TRADITION vs. INNOVATION THE AESTHETIC AND FUNCTIONAL REHABILITATION: TRADITION vs. INNOVATION

Venue: 

Vilafortuny Specialized Training Centre for Healthcare

Date: 

08 December 2016 to 09 December 2016

Phone: 

+971-048864056

Website: 

http://www.vilafortuny.com/dental-training-courses-dubai/

Address: 

Villa 728b, Al Wasl Road, Jumeirah 3
Dubai

Description: 

The presentation will discuss the
fundamentals required to accomplish a
pleasing, functional and long lasting esthetic
outcome: treatment plan, team collaboration,
understanding of the patient’s needs and
selection of restorative materials. A myriad
of factors affect the esthetic and functional
outcome of complex cases. Properly
addressing those factors will facilitate the
achievement of a predictable and successful
prosthetic rehabilitation.

Design Verification data and Process Validation 2016

(73835)
  • Design Verification data and Process Validation 2016
    Design Verification data and Process Validation 2016 Design Verification data and Process Validation 2016

Venue: 

Courtyard Houston Downtown /Convention Center

Date: 

08 December 2016 to 09 December 2016

Time: 

9:00 AM - 6:00 PM

Phone: 

+971-18004479407

Website: 

http://bit.ly/2e8BvgT-Statistical-Methods

Address: 

916 Dallas Street Houston Texas
77002

Description: 

Overview:
This 2-day seminar provides a 1-day introduction to the statistical tools used to analyze Design Verification data and Process Validation results. The entire 2nd day is spent on Statistical Process Control and Process Capability Indices. The goal of the 1st day is to help the student understand how to choose statistical methods and sample sizes, and to correctly interpret the results. The goal of the 2nd say is to explain how to monitor a validated production process, using tools that can also help improve product quality.
Why should you attend?
All design and/or manufacturing companies perform design verification and/or process validation studies. A clear understanding of relevant statistical principles and statistical methods ensures that such studies are efficient and accurate. In addition, all validated processes must be monitored to ensure their continued suitability (per the FDA).
The statistical methods used for such activities are easily misused when their fundamental principles are not well understood. Mistakes in usage can lead to new products being launched that should have been kept in R&D; or, conversely, can lead to erroneously deciding to not launch a new product. And failure to monitor production processes accurately can lead to a slow decline in product quality.
This seminar provides a thorough, practical introduction to the relevant statistical methods and principles that will help ensure that outputs from R&D, Product Transfer, Manufacturing Engineering, and Production are consistently of high quality.
Areas Covered in the Session:
• FDA, ISO 9001/13485, and MDD requirements
• Statistically valid rationales for sample sizes
• The interpretation of statistical significance and statistical non-significance
• The impact of normality and non-normality
• Tests of Normality
• Transformations to Normality
• Concepts of "Confidence" and "Reliability" (a.k.a., %-in-specification)
• Concepts of "Quality" and "Variability" and "Process"
• Risk management
Who will benefit:
• QA/QC Supervisor
• Process Engineer
• Manufacturing Engineer
• QC/QC Technician
• Manufacturing Technician
• R&D Engineer
Agenda:
Day 1 Schedule:

STATISTICAL ANALYSIS OF DESIGN VERIFICATION DATA AND PROCESS VALIDATION RESULTS
Lecture 1: Regulatory requirements
Lecture 2: Basic vocabulary and concepts
Lecture 3: How to interpret Linear Regression Correlation coefficients
Lecture 4: How to calculate Confidence Intervals (for proportions & for measurements)
Lecture 5: How to perform and interpret simple t-Tests of Statistical Significance, including consideration of "p-values" and sample-size, and the concepts of "superiority" and "non-inferiority".
Lecture 6: Calculation of confidence and reliability (= % in-specification) for
• attribute data
• normally-distributed variables data (including Tests of Normality)
• non-normal data (including Transformations to Normality)
• non-normal data that cannot be transformed to normality
Day 2 Schedule:

STATISTICAL PROCESS CONTROL (SPC) AND PROCESS CAPABILITY INDICES
Lecture 1: What is Quality?
Lecture 2: Process Variation
Lecture 3: What is Statistical Process Control?
Lecture 4: Basic Types of Control Charts and how to construct them: XbarR, XbarS, XmR, P, and U.
Lecture 5: Control Limits: Calculation & Re-calculation
Lecture 6: Out of Control: How to Detect It, & What to Do if Detect It?
Lecture 7: Sample Issues: Random, Sub-grouping, & Sample Size
Lecture 8: Capability Indices and how to calculation them
Lecture 9: Non-normal Data, and its impact on SPC.
Lecture 10: How to Initiate & Implement a Successful SPC Program
Speaker:

John Zorich
Statistical Consultant & Trainer, Ohlone College & SV Polytechnic

John N. Zorich, has spent 35 years in the medical device manufacturing industry; the first 20 years were as a "regular" employee in the areas of R&D, Manufacturing, QA/QC, and Regulatory; the last 15 years were as consultant in the areas of QA/QC and Statistics. His consulting clients in the area of statistics have included numerous start-ups as well as large corporations such as Boston Scientific, Novellus, and Siemens Medical. His experience as an instructor in statistics includes having given 3-day workshop/seminars for the past several years at Ohlone College (San Jose CA), 1-day training workshops in SPC for Silicon Valley Polytechnic Institute (San Jose CA) for several years, several 3-day courses for ASQ Biomedical, numerous seminars at ASQ meetings and conferences, and half-day seminars for numerous private clients. He creates and sells formally-validated statistical application spreadsheets that have been purchased by more than 75 companies, world-wide.

Location: Houston, TX Date: December 8th & 9th, 2016 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Houston Downtown /Convention Center
Address: 916 Dallas Street Houston Texas 77002 USA Phone: +1 832-366-1600

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar fee for one Delegate Without Stay)

Until October 15, Early Bird Price: $1,295.00 from October 16 to December 6, Regular Price: $1,495.00

Price: $1,695.00 (Seminar fee for one Delegate With Stay)

Until October 15, Early Bird Price: $1,695.00 from October 16 to December 6, Regular Price: $1,895.00

Register for 5 attendees (With stay) Includes Price: $4,323.00 $8,475.00 You Save: $4,152.00 (49%)*

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/2e8BvgT-Statistical-Methods
Follow us: https://www.linkedin.com/company/globalcompliancepanel

Best Practices for FDA Inspection 2016

(73834)
  • Best Practices for FDA Inspection 2016
    Best Practices for FDA Inspection 2016 Best Practices for FDA Inspection 2016

Venue: 

Embassy Suites Boston at Logan Airport

Date: 

08 December 2016 to 09 December 2016

Time: 

9:00 AM - 6:00 PM

Phone: 

+971-18004479407

Website: 

http://bit.ly/2dWFyPt-FDA-Inspection

Address: 

207 Porter St.
Boston, MA
02128

Description: 

Overview:
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.
Who Will Benefit:
This seminar will provide valuable assistance and guidance to all regulated companies that are preparing for FDA inspections. The employees who will benefit include:
• All levels of Management for all departments
• QA/QC/Compliance/Regulatory Affairs
• Information Technology/Marketing & Sales
• Engineering/Technical Services/Validation
• Consultants
• Operations and Manufacturing
Agenda:
Day 1 Schedule:

Lecture 1: How a firm should prepare for an FDA inspection
Lecture 2: Ways to train employees in view of the inspection
Lecture 3: How to ensure that required documentation is in place
Lecture 4: How to interact with the investigator-DO and DON'T's
Lecture 5: What companies should do when the inspection ends
Lecture 6: How to reply to 483's and warning letters
Lecture 7: Legal implications of non-compliance
Lecture 8: Post inspection actions
Day 2 Schedule:

Lecture 1: Why inspections are conducted and by what statutory authority
Lecture 2: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents
Lecture 3: What is subject to FDA purview and what's off-limits
Lecture 4: Understand and apply the do's and don'ts and comprehend that preparation is the key to success
Lecture 5: What are the prohibited "Acts" and the enforcement categories that you need to deal with
Lecture 6: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key
Lecture 7: the Company’s Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel
Lecture 8: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure
Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development
Speaker:

David R. Dills
Regulatory Affairs & Compliance Consultant,

David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, postmarketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.

Location: Boston, MA Date: December 8th & 9th, 2016 and Time: 9:00 AM to 6:00 PM

Venue: Embassy Suites Boston at Logan Airport
Address: 207 Porter St. Boston, MA 02128

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar fee for one Delegate - Without Stay)

Until October 20, Early Bird Price: $1,295.00 from October 21 to December 6, Regular Price: $1,495.00

Price: $1,695.00 (Seminar fee for one Delegate - With Stay)

Until October 20, Early Bird Price: $1,695.00 from October 21 to December 6, Regular Price: $1,895.00

Register for 5 attendees (With stay) Includes Price: $4,323.00 $8,475.00 You Save: $4,152.00 (49%)*

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/2dWFyPt-FDA-Inspection
Follow us: https://www.linkedin.com/company/globalcompliancepanel

Usa 2016 webinar by Compliance4all on Construction of the European Drug Master File

(73791)
  • Usa 2016 webinar by Compliance4all on Construction of the European Drug Master File
    Usa 2016 webinar by Compliance4all on Construction of the European Drug Master File Usa 2016 webinar by Compliance4all on Construction of the European Drug Master File

Venue: 

Online

Date: 

08 December 2016

Time: 

10:00 AM - 11:00 AM

Phone: 

+971-18004479407

Website: 

http://bit.ly/2dDhyhD

Address: 

161 Mission Falls Lane, Suite 216
94539

Description: 

Overview:
Drug master files serve as documentation on the quality of an active ingredient or excipient and are submitted by a manufacturer as part of the licensing or amendment procedure.

Confidential information from the manufacturer must be protected. However, at the same time the license-holder must receive all the information it needs in order to takeresponsibility for the quality of a medicinal product.

Areas Covered in the Session:
Examine the background and history with the EDMF
Learn step-by-step how to construct and submit the EDMF (and this is not FDA's DMF)
DMF’s today are mostly prepared following the rules of Common Technical Documentation (CTD)
Understand that this is a document containing the information required to demonstrate that the quality of the active substance is adequately controlled by the specification proposed by the applicant
Expectations for Applicant's part and ASM Restricted Part of the EDMF

Who will benefit:
This webinar will provide valuable assistance and guidance to manufacturers who must prepare and submit the Drug Master File (Active Substance Master File) to European Competent Authorities. Employees who will benefit include:
All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the EDMF process and expectations
Regulatory Affairs
Clinical Affairs
Quality and Compliance
Marketing & Sales
Distributors/Authorized Representatives
Engineering/Technical Services/Operations
Consultants

Speaker Profile:
David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=500840LIVE?c...
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