Conferences and Meetings on Regulation in Medicine and Pharmacology

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1
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:
1059984
2
510(k) Submissions to the FDA — 510(k) Submissions to the FDA: Hands-On Workshop
26 Jul 2018 - 27 Jul 2018 • Boston, United States
Abstract:
This hands-on workshop is done by one of the industry’s top regulatory expert. The trainer has performed numerous reviews of 510(k) submissions over the last 15 years, and has analyzed the reasons that most often lead to delays in getting submissions ultimately cleared by FDA. This hands-on workshop will walk the attendees through the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.
Contact:
Peter Brown;     Phone: [410-501-5777];     Email: pbrown@fdamap.com
Topics:
FDA 510k submission, 510k regulations, FDA 510k guidance, FDA regulations, FDA Submission, 510k process
Event listing ID:
1093195
3
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:
1046934
4
Course — European Regulatory Procedures - EMA & National Requirements
13 Sep 2018 - 14 Sep 2018 • Berlin, Germany
Abstract:
This course will give participants the necessary overview of the application procedures and regulatory filing pathways used within Europe to grant marketing authorisations for medicinal products, and of the agencies and institutions that control the regulatory process. Special focus will be given to the European Medicines Agency (EMA) and the Centralised Procedure (CP), with the role of the national health authorities and other EU bodies in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) explained also. Factors affecting the choice of procedure will be discussed, as well as best practice in the management of the procedures. A workshop session will engage participants in a case study evaluating the options for submission of a marketing authorization application.
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
European Regulatory Procedures, Regulation, EMA, Centralised Procedure, European Medicines Agency, Filing Strategy, Labeling
Event listing ID:
1012351
Related subject(s):
5
Clinical Trial Supply Chain Strategy Meeting Europe 2018
27 Sep 2018 • Radisson Blu Hotel, Zurich Airport, Switzerland
Abstract:
The Clinical Trial Supply Chain Strategy Meeting Europe 2018 gathers c-level executives from large to emerging biotech and pharma companies to discuss shared industry challenges and work together to strategize for short and long term goals. This is happening at Radisson Blu, Zurich Airport in Switzerland on 27 September 2018.
Contact:
Phone: [+44 20 70961222];     Email: jp@proventainternational.com
Topics:
clinical trial management, clinical data systems, clinical operations, supply chain, direct-to-patient
Event listing ID:
1054711
6
The Pharma Licensing Negotiation Course
27 Sep 2018 - 28 Sep 2018 • Brussels, Belgium
Abstract:
Learn and practice in role plays the whole armamentarium of winning strategies, tools, dos & don’ts, tricks & tips in each step of the pharma licensing negotiation process: planning – internal negotiations – making the first contact – term sheet assumptions – face-to-face meetings – resolving issues – contract closure.
Contact:
Phone: [+32 2 709 01 42];     Email: annelies.swaan@celforpharma.com
Event listing ID:
1009988
7
IAMRA 2018 — 13th International Conference on Medical Regulation 2018
06 Oct 2018 - 09 Oct 2018 • Dubai, United Arab Emirates
Abstract:
Hosting the 13th International Association of Medical Regulatory Authorities is a reflection of Dubai’s capabilities in being a home to such a prominent event.
Contact:
Phone: [43116300];     Email: nida.nafis@mci-group.com
Event listing ID:
1036635
Event website:
8
BIOTRAINS — Lyotalk USA 2018 : Largest conference on Freeze Drying/Lyophilization
10 Oct 2018 - 11 Oct 2018 • Orlando, Florida, India
Abstract:
Lyotalk is USA's largest annual conference on Lyophilization/Freeze Drying. Lyotalk attracts gathering from of 150+ experts from pharma, biotech and Academia from USA and rest of the world for 2 days of learning of latest technology and networking, discovering new opportunities and partnerships.The event covers a wide spectrum from formulation, Development, Production, manufacturing and regulatory affairs topics such formulation strategies, Scale-up, cycle development & optimization, Regulatory compliance, Quality by Design (QbD) , PAT process design, Ice Nucleation, Case studies & troubleshooting, New developments in freeze drying, Process development for generics, proteins, biologics and vaccines.Lyotalk 2018 is a two day program that features presentations, case studies, interactive round tables, panel discussion and workshop facilitated by industry experts. The first day covers talks and presentations and day 2 is dedicated to workshops/training.
Contact:
Biotrains;     Phone: [09876543210];     Email: marketing@biotrains.com
Topics:
CURRENT REGULATORY CONSIDERATIONS, FORMULATION STRATEGIES & DESIGNS, PAT TOOLS TO MONITOR, THE LYOPHILISATION PROCESS, EFFICIENT MANUFACTURING SYSTEMS, BULK FREEZE DRYING, FREEZE DRYING OF PROTEINS, LATEST TECHNOLOGY & DEVELOPMENTS, PROCESS CONTROLS - VACUUM & SHELF TEMPERATURE, HEADSPACE MOISTURE ANALYSIS
Event listing ID:
1093197
9
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:
1053950
10
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:
1068041
11
Course — Filing Variations in the European Union
07 Nov 2018 - 08 Nov 2018 • Berlin, Germany
Abstract:
The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections.
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
filing, extensions, Marketing Authorizations, filing variations, CMD, Submission, Timeline
Event listing ID:
1012506
12
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:
1068106
13
Euro toxi summit 2018 — Euro Summit on Toxicology & Pharmacology
19 Nov 2018 - 21 Nov 2018 • Rome, Italy
Abstract:
Scient Open Access extends an enthusiastic and sincere welcome to the Euro Summit on Toxicology & Pharmacology which is set to hit the calendar in November 19-21 at Rome, Italy. The Euro Toxicology Conference is the nation’s biggest, most influential collaboration of professionals dedicated to Toxicology & Pharmacology.
Contact:
Phone: [15199000130];     Email: genotoxicology@scientonline.org
Topics:
Scientific Sessions Track 1 Toxicology Track 2 Applied Toxicology Track 3 Drug Toxicology Track 4 Pharmacology and Toxicology Track 5 Environmental Toxicology Track 6 Immunotoxicology Track 7 Applied Pharmacology Track 8 Forensic Toxicology Track 9 Reproductive Toxicology Track 10 Genetic Toxicology Track 11 Toxicology Current Advances Track 12 Industrial & Occupational Toxicology Track 13 Trending Toxicology Concepts Track 14 Computational toxicology Track 15 Clinical Pharmacology Track 16 Cardiovascular Pharmacology
Event listing ID:
1053358
14
The Pharmaceutical Out-licensing Course
27 Nov 2018 - 28 Nov 2018 • Brussels, Belgium
Abstract:
Be able to decide on the best deal type for products in R&D – Know what to include in CDAs, MTAs and term sheets – Learn how to prepare product information and how to find potential partners – Know how to calculate the value of your product and optimise the deal structure.
Contact:
Phone: [+32 2 709 01 42];     Email: annelies.swaan@celforpharma.com
Event listing ID:
1010009


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Last updated: 02 June 2018