World Conference Calendar

33683 Conferences

Physical and Life Sciencesrss


Solutions for addressing microbial excursions in medical device, pharmaceutical, and biotech industries - Biotechnology Webinar By ComplianceOnline

Solutions for addressing microbial excursions in medical device, pharmaceutical, and biotech industries - Biotechnology Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-07-2011
This microbial excursions training will address microbial excursion and the best practices for troubleshooting them. Attendees will gain a new understanding of the complexity of troubleshooting outbreaks and contamination issues based on real life experiences and details of specific excursion. Areas Covered in the Seminar: Review data from “real-world” examples. Learn how to develop solutions to your microbial control problems. Learn both the preventative measures and corrective actions. What are the best Practices in contamination prevention. Recent outbreaks of fungal excursions will be discussed and studied. Guidance to identify and rectify Cleaning and Disinfection, Personnel Practices, and Facility Design Flaws.…
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities - Pharmaceutical Webinar By ComplianceOnline

Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities - Pharmaceutical Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-12-2011 Last Day: 01-12-2011
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, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted. 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 DMFs course will take participants through a step-by-step process of DMF preparation and explain the types…
Social Media for Pharma Conference

Social Media for Pharma Conference

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-13-2011 Last Day: 01-14-2011
marcus evans invites you to attend the Social Media for Pharma Conference specific to the needs to of those within the Pharmaceutical, Medical Device and Healthcare Industries. Hear from industry experts as they assess the importance of a distinct social media plan in preparation for FDA guidance in the pharmaceutical industry. Attending this conference will enable you to: 1. Explore the current social media outlets and trends 2. Understand the pending FDA regulatory guidance for social media and how it impacts strategy and compliance 3. Integrate an effective social networking strategy into your organization from a business and compliance perspective…
Establishing Global Drug Substance and Drug Product Specifications – What the Guidelines Don’t Tell You

Establishing Global Drug Substance and Drug Product Specifications – What the Guidelines Don’t Tell You

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-13-2011
Learn how to establish global drug substance and drug product specifications that are appropriate to the phase of clinical development and market application, and understand the types of data that are needed to support these specifications. This session will provide instruction on knowing what to file with the regulatory agencies and when in order to maximize the success of your drug development program. You will learn how important it is to have a thorough understanding of the critical quality attributes of the drug substance and drug product to not only improve your ability to make meaningful decisions during development, but…
Tougher U.S. FDA cGMP Compliance Audits -- Raising the Bar/ Are You Ready? - FDA Webinar By ComplianceOnline

Tougher U.S. FDA cGMP Compliance Audits -- Raising the Bar/ Are You Ready? - FDA Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-18-2011 Last Day: 11-30-2010
This FDA cGMP training webinar will discuss US FDA’s approach to cGMP Audits and expectations from companies. It will also evaluate chief concern areas of cGMP compliance audit and anticipatory emphasis changes as per new regulatory climate. This webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA's CGMP audit "paradigm". Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance. Areas…
Eliminate the Confusion –Annex 13 GMP guide

Eliminate the Confusion –Annex 13 GMP guide

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-21-2011
This GMP webinar will help you understand the compliance requirements concerning Annex 13 of the GMP guide. The session will review the guideline to cover the key areas of compliance including: The role of the "Qualified Person", Packaging, labeling, reconciliations that should take place for each product and each production stage, and Comparator product requirements etc. Areas Covered in the Seminar: Review the role of the "Qualified Person" who must have access to the Product Specification File as the basis for assessment of the suitability for release and certification of a particular batch. Packaging instructions requires expressly with a view…
Full day Virtual Seminar - Compliance for 21 CFR Part 11, reducing costs using risk-based computer system validation

Full day Virtual Seminar - Compliance for 21 CFR Part 11, reducing costs using risk-based computer system validation

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-26-2011
In this CSV seminar learn how to reduce validation project time, efficient documentation strategies, enhance system productivity and increase compliance with the New 21 CFR Part 11 regulations and how to use risk management for improving system performance and process improvement. Why Should You Attend: This interactive one-day virtual seminar provides proven techniques for reducing costs associated with implementing, using and maintaining computer systems in regulated environments. Nearly every computerized system utilized in laboratory, clinical, manufacturing and the quality process has to be validated. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. Explore…
Full Day Virtual Seminar - Understanding Biofilm and Controlling It in Pharmaceutical Water Systems

Full Day Virtual Seminar - Understanding Biofilm and Controlling It in Pharmaceutical Water Systems

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-27-2011
This interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control, arguments for the micro lab being the spearhead of contamination investigations, step-by-step instructions for investigating and resolving microbial excursions in water and associated systems, and how to rationally validate the operation and microbial control in a water systems in a manner that will please FDA. In short, if your job brings you in contact with any aspect of water system design, maintenance, trend monitoring, sampling, testing, sanitization, validation, root cause investigation and response to microbial excursions, or regulatory…
Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements - Webinar By ComplianceOnline

Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements - Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-28-2011
This Design validation 4 hour session will discuss how to write validation protocol and determine acceptance criteria. It will also explain the systematic approach to validate analytical procedures. Areas Covered in the Seminar: Module I. Regulatory Requirements for Analytical Test Methods ( 40 mins) Drug Development Process cGMP requirements for analytical test methods Review ICH Q2 A&B guidelines for method development/validation Module II Development and Validation Stability Indicating Methods ( 35 mins) Design method specificity through forced degradation activities Discuss validation characteristics Module III. Designing Method Validation Protocols ( 35 mins) Establish Method Validation Protocol Establish Method Validation Protocol Module…
2nd Annual Health Outcomes and Pharmaeconomics Research Conference

2nd Annual Health Outcomes and Pharmaeconomics Research Conference

Location: , United States
Category: Physical and Life Sciences
Start Date: 01-31-2011 Last Day: 02-01-2011
Continuing in its Health Outcomes series, marcus evans invites you attend the 2nd Annual Health Outcomes and Pharmacoeconomics Research Conference. Hear from industry leaders within Bio/Pharmaceutical and Medical Device companies on establishing health economic value propositions to maximize your comparative effectiveness strategies. Attending This Conference Will Enable You To: · Review global health economic and outcomes research strategies · Understand comparative effectiveness research trends and regulation · Establish patient reported outcomes and access to data · Create market access, reimbursement and talent management strategies marcus evans invites senior level executives from leading biopharmaceutical and biotech companies in: -Health Outcomes Research…
How to transfer QC procedures for commercial products in pharma industry - ICH and USP guidelines

How to transfer QC procedures for commercial products in pharma industry - ICH and USP guidelines

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-03-2011
Once a product goes commercial, measuring the quality, safety, and efficacy attributes of the drug substance and the drug product is crucial. There are well-established ICH guidelines for the validation requirements of typical analytical procedures. In contrast, the requirements for a technical transfer of an analytical procedure from one site to another or within a site to a separate facility are often debated. It is critical that a robust transfer program be put into place in order to head off issues. Unearthing issues at the drug development stage, rather than during routine manufacture, will improve the overall success of the…
Understanding and Implementing FDA’S 21 CFR Part 11

Understanding and Implementing FDA’S 21 CFR Part 11

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-08-2011
Understand 21 CFR Part 11 requirements and get a guidance how implement it in a cost effective way. Briefing about part 11 inspections. Why Should You Attend: In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even the rule is more than 10 years old there still many questions related to the scope and real requirements of Part…
China - Compliance Processes for Life Science Products: Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations

China - Compliance Processes for Life Science Products: Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-10-2011 Last Day: 02-10-2011
This China life science compliance based webinar will discuss the regulatory structure and requirements for compliance with Chinese SFDA regulations. This 3 hrs course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in China. Content will also include descriptions of the methods by which regulators in the SFDA process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. Who Will…
How to withstand an FDA audit : A primer for clinical sites

How to withstand an FDA audit : A primer for clinical sites

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-10-2011
This FDA Audit webinar training will discuss the types of audit and what are the activities to be done before, during and after FDA audit to pass it successfully and how to increase credibility for your company. Why Should You Attend: If your company is marketing a product or service that is regulated by the FDA, you should be prepared for an FDA audit. If you have never been audited by the FDA or if you were last audited 4-6 years ago, if any product or service you offer has been in the news – positive or negative, or if…
21 CFR Part 212: Quality Systems to Ensure cGMP Compliance

21 CFR Part 212: Quality Systems to Ensure cGMP Compliance

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-11-2011
Learn the new GMP regulation 21 CFR 212, what are the compliance requirements for PET drug manufacturers, how to establish a quality system to ensure cGMP compliance. Why Should You Attend: The new GMP regulation, 21 CFR 212 “Good Manufacturing Practices for Positron Emission Tomography Drugs”, becomes effective on 11 December 2011 and will require all manufacturers of Positron Emission Tomography (PET) drugs to submit either a new drug application (NDA) or abbreviated new drug application (ANDA) for any PET drug product marketed for clinical use in the United States. For PET drugs intended for clinical investigations only or for…
Stability Program to support Shipping and Distribution of Drug Products - Pharma Webinar By ComplianceOnline

Stability Program to support Shipping and Distribution of Drug Products - Pharma Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-17-2011 Last Day: 02-17-2011
Learn the stability studies which need to be done to support shipping and distribution of drugs. 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,…
Particulates in Biological products - Biotech Webinar By ComplianceOnline

Particulates in Biological products - Biotech Webinar By ComplianceOnline

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-18-2011
Understand FDA expectation for reporting for sub-visible particulate testing in biologics injectibles and various methods used for characterization of the sub-visible particles. Why Should You Attend: Particulates in Biologics injectibles can arise from the aggregation of the protein product. It has been suggested that the aggregated material presents a safety concern because it increases the possibility of formation of anti drug antibodies. The FDA has therefore requested BLA sponsors to present sub-visible particulate data at the clinical and commercial stage and has identified the 0.2 - 10 micron as a range where there is a lack of suitable techniques for…
Implementation of Rapid Microbiological Methods

Implementation of Rapid Microbiological Methods

Location: , United States
Category: Physical and Life Sciences
Start Date: 02-24-2011
How to implement Rapid Microbiological Methods to detect, quantify and identify the microorganisms in products, processes and manufacturing environments. How to evaluate RMMs and deploy it in labs and manufacturing areas. Why Should You Attend: Effective monitoring of our manufacturing processes can help to ensure that a state of control is maintained, areas for continual improvement are identified, process and product understanding is enhanced and manufacturing agility and efficiencies are realized. Going away from the old conventional methods, the modern microbiological laboratories should look towards developing innovative approaches to the detection, quantification and identification of microorganisms in our products, processes…
AsiaTIDES Oligonucleotides and Peptide®

AsiaTIDES Oligonucleotides and Peptide®

Location: , Japan
Category: Physical and Life Sciences
Start Date: 03-02-2011 Last Day: 03-04-2011
IBC’s 3rd Annual AsiaTIDES conference is the only event in Japan that gives you the leading research and manufacturing knowledge to fill your pipeline and expand your portfolio. Top pharmaceutical industry experts from around the world will be in attendance to share their experiences and lessons learned. Conference Sessions: •Plenary Session: Keynote Presentations addressing Drug Delivery Challenges and Solutions •Dedicated, Focused Mini Session on microRNA •Oligonucleotides: Updates on Candidates in Preclinical and Clinical Development •Peptides: Updates on Candidates in Preclinical and Clinical Development •Manufacturing and Analytical Development for Peptides and Oligos •Formulation and Delivery of Peptides and Oligos •Business Considerations…
How to Write SOPs: Tips on Writing the Perfect Document to Impress the FDA

How to Write SOPs: Tips on Writing the Perfect Document to Impress the FDA

Location: , United States
Category: Physical and Life Sciences
Start Date: 03-10-2011
This webinar on SOPs will instruct you in creating, managing and implementing adequate SOPs that can impress even the FDA inspectors. Why Should You Attend: Formal and written Standard Operating Procedures (SOPs) are the keystone of good operations. SOPs create an important evidence and documentation for the regulatory compliance status of an organization and are one of the first things auditors wants to review when inspecting a site. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at the given organization. SOPs are often poorly written, communicated, monitored and enforced. Attend…

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