Past Events - Pharmaceutical / Pharmacy Conference in Palm Beach, FL USA
Clinical Project Management
This 6-hr Clinical Project Management training will provide valuable tools and practical tips for initiating, managing, and presenting data from..
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..
Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences
Why you should attend: As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms..
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..
BIG DATA Hadoop Online Training
The level of Big Data training offered by IT experts in H2kinfosys is advanced and extreme and enables students to learn all real time techniques in..
Linking Real World Data with Reimbursement Decisions
Classical clinical trials and conclusions drawn from them are seen as not always useful aid for health care decision-making. The real-world data..
Orphan Drugs Market Access and Regulatory Affairs
Many blockbuster drugs will lose their exclusivity in the next five years. Therefore, the current economic situation has shifted the focus of many..
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..
ATC Radar Approach Control (TRACON)
Overview:
Many people believe that communications, navigation, surveillance, and automation technologies are the elements of the complete ATC system..
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..
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..
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..
Cloud computing for Big Data in Pharma
- Understand how incorporating Cloud solutions for the
pharmaceutical company can raise its performance
- Find out how to instil an enterprise-wide..
Basic GCP and Clinical Research Training for Newcomers
Basic GCP and Clinical Research Training for Newcomers to the Industry (Including Sales Teams) Instructor: Meryl Wiernik Product ID: 500973..
Advances in Cellular Therapy
Discussing advances in rapid disease diagnosis, infection control, and treatment for infectious diseases in the developing world.
GPL Univerity Practitioner Workshops
The Great Plains Laboratory, Inc. is pleased to bring you GPL University, a series of workshops designed to help practitioners learn how to integrate..
