Meetings/Workshops on Regulation in Medicine and Pharmacology in the United States (USA)

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Belgium (2) - Germany (4) - Italy (1) - Switzerland (1) - United Arab Emirates (1) - United Kingdom (1) - United States (8) - ALL COUNTRIES (18)

1
Designing and Sustaining New and Existing Product Stability Testing Program
07 Jun 2018 - 08 Jul 2018 • Orlando, FL, United States
Abstract:
This seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries in understanding the effective way to establish a new or modified product stability testing program. This program is an important part of a product's regulatory filing requirements as well as the determination of the shelf life or expiration date of the product.
Event listing ID:
1046958
2
Seminar — 2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018
28 Jun 2018 - 29 Jun 2018 • Washington DC, United States
Abstract:
2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018

Location 1: Washington DC

Jun 28 - 29

Description

Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.GxP records generated by spreadsheet calculations are electronic records and should comply with FDA’s 21 CFR Part 11 and the European Annex 11. For critical records Part 11 controls, such as data accuracy and data integrity, should be implemented. Currently there are no specific industry FDA guidelines on using spreadsheets in regulated environments. However, the flexibility and power of the spreadsheet allows users to create tools that range from performing simple calculations to sophisticated analysis of a major clinical study, or laboratory or manufacturing data.This makes spreadsheets a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training. However, this has resulted in spreadsheets being among the most under-documented systems used in GxP environments because:

• users regard them as part of the desktop

• the ease with which applications can be built without much training

• the data processing power that they can have

• lack of knowledge that spreadsheets need to be validated

• lack of knowledge on how to validate spreadsheets

Consequently, Spreadsheets have become “low hanging fruit” during FDA or other regulatory inspections and many warning letters have been issued.

Areas Covered

Part 11 / Annex 11 Computer Systems Validation (CSV) is be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets. It will address the following topics:

1. Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.)

2. Risk Based Approach and Controls to Excel Spreadsheets (incl. Excel specific risks)

3. Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11)

4. The FDA’s Perspective and Use of Spreadsheets

5. Examples of Typical Approaches for Excel Validation

6. How to tailor your risk based methodology to Excel to determine the level of validation required

7. 483s and Warning Letters for Excel and other Spreadsheets

8. Quiz: Test your understanding of Computer Systems Validation for Excel

Who will Benefit

• VP of IT

• Director of IT

• Quality Managers

• Project Managers (for CSV / IT)

• Validation Specialists

• Database Administrators

• System Administrators

• Directors / Senior Directors of Discovery

• Directors / Senior Directors of Development

• Directors / Senior Directors of Commercialization

• Document Managers

• Training Managers

• Regulators

Learning Objectives

This 2 Days Workshop is intended for professionals in the

• Pharmaceuticals

• Biotech

• Medical Device

• Radiological Health

• Blood Products

• Companion Animals

• Food

• Cosmetics

• Tobacco

• Academia Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Know Your Speaker

Angela Bazigos

CEO Touchstone Technologies Silicon Valley

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

Venue -

Hilton Garden Inn Washington DC / U.S. Capitol

1225 First Street, NE, Washington, DC 20002

Price -

Seminar One Registration - $ 1295

Special Group Discount Register for Four attendees - $ 3995

URL - https://worldcomplianceseminars.com/seminardetails/29

Contact:
Phone: [844-267-7299];     Email: subscribe@worldcomplianceseminars.com
Event listing ID:
1059982
3
Seminar — 2 DAY SEMINAR Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls
11 Jul 2018 - 12 Jul 2018 • Boston,MA, United States
Contact:
Phone: [844-267-7299];     Email: subscribe@worldcomplianceseminars.com
Event listing ID:
1053940
4
Seminar — 2 Day Workshop: Writing & Managing Effective SOPs
19 Jul 2018 - 20 Jul 2018 • San Francisco, CA, United States
Abstract:
2 Day Workshop: Writing & Managing Effective SOPs

Location 1: San Francisco, CA

Jul 19 - 20

Description

Every biopharmaceutical company has SOPs, and new staff members are told that the company “has to have them” and that each employee “has to follow them”. But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?Most people naturally want to do a good job. Successful managers recognize this fact and seek to channel workers' efforts in ways that will benefit the business. Well-written standard operating procedures (SOPs) provide direction, improve communication, reduce training time, and improve work consistency. The purpose of a SOP is to provide detailed instructions on how to carry out a task so that any team member can carry out the task correctly every time. The SOP development process is an excellent way for managers, workers, and technical advisers to cooperate for everyone's benefit. A very positive sense of teamwork arises when these parties work together toward common goals.Perhaps if everything always executed as planned then we would not need procedures, but this is not the case in the real world. An SOP or Standard Operating Procedure is used to ensure business processes are well thought through, that each task in a process is performed the same way every time, and important data is recorded, along with errors or deviations so corrective action can be taken. Standard operating procedures used in combination with planned training and regular performance feedback lead to an effective and motivated workforce. Managers and advisers benefit from consistent work performance and predictable results. Workers benefit from increased confidence and a clear sense of achievement.Producing a high-quality product at a profit depends on the consistent operation of all systems within the company. SOPs describe the basic systems shared by all company employees. Company success depends on how well these systems work together to produce large volumes of high-quality product that is safe and effective for patients and consumers. Good procedures and work instructions provide a way to communicate and apply consistent standards and practices within your organization.

Areas Covered

At The End Of The Seminar Attendees Will Have Learned:

• Why would I want SOPs?

• What will they do for me?

• How SOPs fit in with laws and regulations

• How to organize the SOP writing effort

• Steps to developing an SOP

• Presenting the SOP

• Educate employees about the new SOP

• Control procedural shift

• Set up an evaluation and review method for continuous SOP improvement

Who will Benefit

This hands-on seminar will help you with creating and following effective Standard Operating Procedures (SOP) to streamline your business and achieve compliance. This seminar will show you how to describe all the tasks that are essential for your business success, how to do these tasks, and who is responsible for the tasks listed.

Specific benefits include:

Reduced learning curve/training time for new employees

When someone is new on the job, your well-written and researched SOP can be a lifeline to them to be able to know how things work. For instance, you can ask your new employee to make all the arrangements for you to organize and attend a workshop in another city. By referring to the SOP, your new employee will know exactly which travel agency you use with their contact details, which type of car to hire/service to use, how many quotes to get regarding the venue, how to communicate with the workshop delegates, etc. without having to ask you about it all. It’s a great time-saver and confidence booster for the new employee.

Ensured business continuity

When a key staff member is on leave or not in the office for some reason, work does not have to stand still. By referring to the SOP someone else can take over the urgent tasks and do them correctly the first time.

Standardized processes

The SOP makes it easy to find out what policies and procedures are in place to handle repetitive situations/tasks.Delegating tasks becomes a no-brainer

A good SOP will include the organogram of the business, as well as have a short job description and contact details for each staff member. If you need to delegate a certain task, you can see at a glance who will be able to help you or advise you. You can stop micromanaging, as it is clear who is responsible for what.Ensure that your clients are getting the best possible experience with you

Because there is a standard way of dealing with client queries, refunds, promotions, follow-up etc., you can make sure that each client is treated fairly and equally, enhancing their interactions with you. You thus provide the best possible client service.A SOP is a living document, which is subject to change. (It is good to review it quarterly). It is therefore useful to have it in electronic format on a web-based collaborative system so that all employees have access to the latest version.Do you need to put together a clear and straightforward SOP, compiled in simple language to convey practical information. Your business will thank you for it!

Learning Objectives

• Pharmaceuticals

• Biotech

• Medical Device

• Radiological Health

• Blood Products

• Healthcare

• Companion Animals

• Food

• Cosmetics

• Tobacco

• Academia

Know Your Speaker

Angela Bazigos

CEO Touchstone Technologies Silicon Valley

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

Venue -

Homewood Suites by Hilton San Francisco

2000 Shoreline Court | Brisbane CA 94005 | USA

Price -

Seminar One Registration - $ 1295

Special Group Discount Register for Four attendees - $ 3995

URL - https://worldcomplianceseminars.com/seminardetails/41

Contact:
Phone: [844-267-7299];     Email: subscribe@worldcomplianceseminars.com
Event listing ID:
1060017
5
HACCP — Principles and Application of Hazard Analysis Critical Control Point
08 Aug 2018 - 09 Aug 2018 • New York, NY, United States
Abstract:
The Principles and Applications of HACCP course is designed to teach participants how to develop, implement and maintain a Hazard Analysis Critical Control Point (HACCP) system. The training is presented over 2 days which cover the 5 preliminary steps and the 7 principles of HACCP. Practical examples and activities are provided to assist with development and implementation within your food business. Additionally, participants will learn techniques for managing both HACCP and pre-requisite programs to ensure food products are safe and suitable for customers and consumers. This course is facilitated by an International HACCP Alliance qualified trainer with a certificate of competency provided to all participants who successfully complete the in-course activities and assessments.
Event listing ID:
1046989
6
Seminar — 2018 Data Integrity Seminar : FDA/EU Requirements and Implementation
11 Oct 2018 - 12 Oct 2018 • Boston,MA, United States
Contact:
Phone: [844-267-7299];     Email: subscribe@worldcomplianceseminars.com
Event listing ID:
1053983
7
Pharmacovigilance Strategy Meeting US East Coast 2018
07 Nov 2018 • Massachusetts, United States
Contact:
Phone: [2070961222];     Email: jp@proventainternational.com
Topics:
regulatory affairs, compliance, epidemiology, drug safety, risk management
Event listing ID:
1068063
8
Regulatory Affairs Strategy Meeting US East Coast 2018
08 Nov 2018 • Massachusetts, United States
Contact:
Phone: [2070961222];     Email: jp@proventainternational.com
Topics:
regulatory affairs, compliance, epidemiology, drug safety, risk management, medical safety
Event listing ID:
1068128

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Last updated: 13 May 2018