Past Events - Medicine Conference / Show in Palm Beach, FL USA
Risk-Based Validation for GxP Facilities
Overview: This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this..
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Why you should attend: Expectations for meaningful CAPA, supported by results-driven Failure Investigation and Root Cause Analysis, that addresses and..
International Scientific Congress “Precancerous lesions and changes of the stomach”
December 10 - 20, 2012 International Scientific Congress “Precancerous lesions and changes of the stomach” is going to be held.Sectoral Congress:..
Health protection and physical development of a person in conditions of the biospheric crisis
February 21-26, 2013 the first stage of research analytics championships and XLV International Research and Practice Conference "Health protection and..
International Research and Practice Conference "Medical and pharmacological resources"
October 24-29, 2013 the third stage of research analytics championships and LXIX International Research and Practice Conference "Medical and..
International Research and Practice Conference "Development of species and processes"
The International Academy of Sciences and Higher Education (Great Britain) and their partners invite you to take part in research analytics..
Pharmaceutical Regulatory Affairs in ASEAN: Best practices in Drug Registration
Discuss the drug registration process in regards to the upcoming harmonisation in ASEAN countriesLearn about the current regulatory environment in..
Regulatory Affairs in Biosimilars EU vs US
By the end of this decade, a significant number of blockbuster drugs will go off patent, allowing a large number of biosimilar products to enter the..
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will..
The Most Common Problems with Software Validation Processes
This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company..
Measurement Uncertainty in Microbiology
Many microbiology laboratories are confused about what MU is, how to calculate it and how to apply it. We will discuss what is needed to meet the..
Key Concepts in Successful Water System Sanitization
Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction,..
ICH GCPs and the Clinical Research Process (Including Phase 0,1,2,3 and Phase 4 trials)
This webinar provides all the necessary information concerning the ICH GCP-the only global GCP. ICH GCP is not only the only global GCP it is also the..
Excel Spreadsheet Validation for FDA 21 CFR Part 11
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then..
Techniques of ensuring the duration and quality of biological life Conference
International Academy of Sciences and Higher Education (Great Britain) and their partners invite you to take part in research analytics championship..
GMP Expectations for Products Used in Early Phase IND Studies
Overview:
FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are..
International Regulatory Cooperation Among Agencies
Overview:
This presentation will review what we know of how regulatory agencies are working together internationally to share best practices in..
Medical Packaging Validation Strategies, Planning for Success
Overview:
Compliance to ISO 11607, Parts 1 and 2 require that Packaging Sterile Barrier Systems and Packaging Processes be validated. Validation..
FDA's Foreign Inspections Requires Special Management
Overview:
Foreign manufacturers face special difficulties when FDA conducts an inspection. The logistics of scheduling an inspection involve much..
Complaint Handling in Compliance with FDA and ISO Regulations
Overview:
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process..
How to Handle Corrections & Removals under 21 CFR 806
Overview:
As an experienced FDA medical device investigator, at one time or another many firms I’ve inspected have struggled with deciphering the..
Auditing Enterprise Risk Management
Overview:In 2004, the Committee of Sponsoring Organizations of the Tread way Commission (COSO), issued a principle-based guidance on designing and..
Paediatric Investigation Plans (PIP) in the EU
Overview:The European Medicines Agency plays an important role in the development of medicines for children. In the past, many medicines authorized in..
Better Alternatives to Sampling Plans
Overview:The webinar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to..
Confidence-Reliability Calculations and Statistically Valid Sample Sizes
Overview:
The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some..
A second look at 510(k) changes webinar
Overview:The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not..
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Overview:Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations,..
Conducting Successful Product Complaint Investigations - Compliance4All
Overview:An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any..
Neurology & Psychiatry
Graduatecentral.com is a novel & pioneer initiative where graduates can publish their innovative thoughts, sharp & excellent ideas, reports, novel..
Pharmaceutical Market Access in the USA Webinar
Achieving patient access in the USA has never before been so challenging and the market is extremely complex, fragmented and dynamic like never..
DIALOGO-CONF - Virtual International Conference on the Dialogue between Science and Theology
The goal of the Virtual Conference on the Dialogue between Science and Theology is twofold. First it aims to collect high-quality, authoritative,..
Validation of Complex Cell-Based Potency Methods
Acquire knowledge on complex cell-based methods, selection of the method and the cell line, and correlating the method with the pharmaceutical..
Pre-Clinical Models for Drug Development-Syngeneic Models
A thorough guide on drug development right from drug discovery, development, pre-clinical models, SCID mouse models, syngeneic murine models, clinical..
