As Hospitals and Clinics today do more clinical trials they must prepare their staffs to be ready to do clinical trials. This Webinar will introduce the attendees to the issues that occur during a clinical trial that must be monitored and managed.

Overview: This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training. Also contained in this session will be a section-by-section summary of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.

Why you should attend: What should I expect the FDA investigator to look at when they visit? The FDA inspection can be much easier to handle and manage if you know what to expect. Advance knowledge will enable you to prepare for the FDA inspection. This knowledge and planning will make the inspection experience much less stressful, and assure better compliance.

Areas Covered in the Session:
How to prepare for an FDA inspection?
Development and contents of an SOP for FDA inspection.
Reliance of FDA inspectors on compliance program guide manuals.
Reliance of FDA inspectors on other external sources.
Personnel training before inspection.
In depth review and summary of QSIT.
Use of QSIT for internal auditing.

Who Will Benefit: This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
Executive/Senior Management
Regulatory Management
QA Management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality System Auditors

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Overview: This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training. Also contained in this session will be a section-by-section summary of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.

Why you should attend: What should I expect the FDA investigator to look at when they visit? The FDA inspection can be much easier to handle and manage if you know what to expect. Advance knowledge will enable you to prepare for the FDA inspection. This knowledge and planning will make the inspection experience much less stressful, and assure better compliance.

Areas Covered in the Session:
How to prepare for an FDA inspection?
Development and contents of an SOP for FDA inspection.
Reliance of FDA inspectors on compliance program guide manuals.
Reliance of FDA inspectors on other external sources.
Personnel training before inspection.
In depth review and summary of QSIT.
Use of QSIT for internal auditing.

Who Will Benefit: This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
Executive/Senior Management
Regulatory Management
QA Management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality System Auditors

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! 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. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits

Areas Covered in the Session:

How to prepare for an FDA inspection

Development and contents of an SOP for FDA inspection

Personnel training before inspection

How to behave during an inspection

Limitations of scope of inspection

Response to investigation findings

FDA guidance documents used by their inspectors

Webinar Includes:

-Q/A Session with the Expert to ask your question

-PDF print only copy of PowerPoint slides

-60 Minutes Live Presentation

Who will benefit: The designations

This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

Executive/senior management
Regulatory management
QA management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality system auditors

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of the FDA’s regular inspections. This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11.

Why should you Attend:

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections.

At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003.

In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations. This webinar will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

Areas Covered in the Session:

- What is FDA's most current thinking related to computers and electronic records?
- What are the inspection trends?
- What are most frequent recent citations for Part11?
- What are the most frequent deviations for computer system validation?
- Under which circumstances can inspectors exercise enforcement discretion?
- How important is risk based Part11 compliance?
- What is the best strategy for future proven Part 11 compliance?

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Who will Benefit:

* Everybody using computers in FDA regulated environments
* IT manager and staff
* QA managers and personnel
* Regulatory affairs
* Training departments
* Consultants
* Validation specialists

About Speaker

Angela Bazigos has been accepted into the prestigious ranks of Stanford Who’s Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world.

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years experience in the Life Sciences industry spanning project management, Quality Assurance and Regulatory Affairs. She has applied for patents aimed at speeding up Software Compliance and FDA Audits.

Angela is a member SQA (Society of Quality Assurance) as well as of the SQA CVIC (Computer Validation Initiative Committee), DIA and RAPS. She provides consulting services to Pharma, Biotech, Medical Device and CRO industries on compliance matters, including strategy, submissions, quality assurance, computer systems validation, and remediation’s following action by the FDA. She also teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management.
More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research, Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is also on the board for UC Berkeley’s Haas Business School for Executive Education in Life Sciences.

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.
Upon completion of this course, attendees will understand how to prepare and file DMFs with the FDA and the rationale behind doing so. Participants will gain practical knowledge about what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance, and strategies for avoiding the most common DMF-related errors. The course will also emphasize the "organic" nature of DMFs , present strategies for establishing and maintaining effective change control programs , along with facilitating effective communications with regulatory agencies and your own customers and vendors.

Why Should You Attend

This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. The DMFscourse will take participants through a step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.

The course offers methodologies and techniques on:

Who really needs a DMF and why?
The various types of DMFs - which is best for your products.
The relationship between DMFs and drug and biologics applications.
The symbiotic relationship between DMFs and current Good Manufacturing Practices (cGMPs).
Common DMF errors - how to avoid them.
How to deal with deficiency letters and their origins.
Effective change control strategies.
Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspectional trends.

Seminar Agenda
What are DMFs?
Types of DMFs (Types II, III, IV and V)

The rationale and preparation process for DMFs
Why DMFs are important to you and your company
How DMFs fit into FDA's regulatory processes for review of drug and biologic applications
Why, more than ever, you may need DMFs to maintain current supplier agreements as well as to develop new business relationships
What not to include

DMF Preparation: What you need and why you need it

The essential components of all DMFs, including:
The relationship between DMFs and cGMPs
Tactics for avoiding the most common DMF-related errors
Tactics for dealing with unique or novel situations/unfavorable reviews
.
FDA Review: How FDA reviews DMFs and why.
What you should expect throughout the DMF preparation and filing process
How to communicate and work with FDA to ensure success

Components Associated with a DMF:
DMF vs. Application
Acknowledgement Letter
Letter of Authorization
Changes to a DMF
Annual updates
Obligations of a DMF holder
Transmissions - transmittal letter
Deficiency letter
Auditing Vendor
Inside tips
Changes to DMF system in last 10 years
Binder specifications and cover sample

Japan DMFs
European DMFs
Canadian DMFs
Change control and maintenance: Why accurately maintaining your DMFs is important
DMFs as "living" documents. DMF updates and amendments
Types of DMF-related changes that impact drug/biologic applications: production facilities, composite materials, manufacturing processes
What you must report and to whom - the importance of establishing communication pathways with regulatory agencies, customers and vendors

Who Will Benefit:

This course is developed for those involved in the manufacture of pharmaceutical and biologic products, components, and packaging materials. The course will be especially useful for personnel responsible for:

Manufacturing
Regulatory Affairs
Research and Development
Quality Assurance & Control
Validation
Development and Preparation of Submission Materials

About Speaker

Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.

The terms Fair Lending and UDAAP tend to strike fear and panic in the hearts of many financial industry professionals due to their over-arching and vastly subjective interpretations. Unlike more "traditional" regulations these two fundamental pillars of ethical banking interweave the grey areas that connect the regulatory environment with risk management. The end result is a veritable mine field for even the most seasoned financial industry professionals when it comes to balancing successful business operations and consumer protection. The goal of this webinar is to help demystify these terms and provide you with a better way forward for managing the risks associated with these aspects of consumer protection.

Why should you attend:

Current and future compliance professionals, lenders, loan originators, board of directors, senior management. Anyone responsible for the development, marketing, and sales of bank products or services.

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Areas Covered in the Session:

The goal of consumer protection rules in banking

The risk scenarios UDAAP and Fair Lending create

The hidden simplicity of UDAAP and Fair Lending risk management

The pratfalls of consumer protection

The synergy between Fair Lending, UDAAP and your business goals.

Who will benefit: (Titles)

Board of Directors Members
Executive Officers
Senior Officers
Compliance Officers
Risk Managers
All commercial and consumer Lending Department employees
Bank Operations Managers
Branch Managers

About Speaker

Asaad A. Faquir is currently a Compliance Officer for a growing community bank in New England. He began his career in banking as an Operations and Management Consultant for a large multi-billion dollar bank in South Florida. Asaad has a BS in Finance from Florida State University, an MBA in Finance from Temple University and a Masters Degree in Human Resource Management from the University of Limerick in Limerick, Ireland where he focused his Masters Thesis on Strategic Leadership, while attending school as a Rotary International Ambassadorial Scholar. Asaad has conducted successful webinars in the areas of risk and compliance and has been an Adjunct Professor of Human Resource Management.

Description

Overview: Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.

Areas Covered in the Session

- FDA and ISO requirements for complaint handling

- Establishment of complaint handling program

- What constitutes a complaint

- ISO-specific implications of complaint handling

- The roles of investigation and corrective action in complaint handling

- Complaint trending and reporting

- Application of risk management to complaint handling program

Who will benefit: (Titles)

This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

· Regulatory Management

· QA Management

· Customer Service Personnel

· Sales Personnel

· Quality System Auditors

· Consultants

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

description

Attendees will receive free document on Review of ISO14001 standard; review of ISO 9001 standard - learn similarities nd differences.

"The ISO 14000 environmental management standards exist to help organizations minimize how their operations (processes etc.) negatively affect the environment (i.e. cause adverse changes to air, water, or land); comply with applicable laws, regulations, and other environmentally oriented requirements, and continually improve in the above.

The concept of an environmental management system evolved in the early nineties and its origin can be traced back to 1972, when the United Nations organised a Conference on the Human Environment in Stockholm and the United Nations Environment Programme (UNEP) was launched (Corbett & Kirsch, 2001). These early initiatives led to the establishment of the World Commission on Environment and Development (WCED) and the adoption of the Montreal Protocol and Basel Convention.

In 1992, the first Earth Summit was held in Rio-de-Janeiro (Jiang & Bansal, 2001), which served to generate a global commitment to the environment (RMIT University). In the same year, BSI Group published the world's first environmental management systems standard, BS 7750.[1] This supplied the template for the development of the ISO 14000 series in 1996, by the International Organization for Standardization, which has representation from committees all over the world (ISO) (Clements 1996, Brorson & Larsson, 1999). As of 2010, ISO 14001 is now used by at least 223 149 organizations in 159 countries and economies

Description of the Topic:

Overview of the regulation, its benefits to organizations, elements of auditing for ISO 14001, training requirements, awareness, and implementation, some of the lessons learned and most commonly asked questions.

Areas Covered in the Session

- Overview of the standard

- Implementation tips and suggestions

- Benefits of implementation and compliance

- Auditing elements related to ISO 14001

- Increasing awareness and communications

- Lessons learned

Who will Benefit

- Quality Managers

- EHS managers

- Small business owners

- CAPA investigators

- Project managers

- Operations managers

- Consultants

- Review of ISO14001 standard; review of ISO 9001 standard - learn similarities and differences

About Speaker

Jasmin NUHIC serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696
https://www.compliance2go.com/index.php?option=com_training&speakerkey=8...

description

Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system.

Areas Covered in the Session

- QSR and ISO 13485 requirements for document control

- Description of typical document control system in use

- Streamlined document control process

- Paper-free document review

- Immediate document distribution

Who will benefit: (Titles)

The employees who will benefit include:

· Executive Management

· Document Control Management

· Document Control Clerks

· Consultants

· Quality system auditors

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696
https://www.compliance2go.com/index.php?option=com_training&speakerkey=8...