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Title Dates Register

Dissolution, Bioequivalence & Bioavailability:

* An Insider's Look into Biopharmaceutic Classification System (BCS) and Biowaivers
* Determining BCS Class II and III Dissolution Requirements and Specifications
* Enhancing the Bioavailability of Poorly Water Soluble Drugs
* Review Recent Regulatory Initiatives and Current Inspection Trends to Ensure Compliance, Including Conducting Out-of-Spec (OOS) Results Investigations
* Discover New Developments in BA and PK Assessments
* Analyze Individual Bioequivalence (IBE) Current Status and Lessons Learned
* Evaluate In-Situ Testing Using Various UV Fiber Optic Probes/Instruments

In-Depth Focus on Common Pitfalls and Evolving Challenges
* Implementing Best Practices for Poorly Soluble Drugs and Novel Dosage Forms: Nanospheres, Microspheres, Implants, Suppositories, Surfactants, Soft and Hard Gel Caps, Calibration, Methods Validation
* Bio-Relevant Dissolution Testing: Considerations and Proven Strategies
* Applying Proven Strategies for In Vivo In Vitro Correlations (IV/IVC)

Washington, DC  
06/23/2013 - 06/24/2013 [Register]

Network Infrastructure Qualification & Systems Validation:

* Develop strategies for network infrastructure qualification and systems validation
* Understand qualification of individual hardware components, software and software configuration
* Learn how to apply an appropriate IT infrastructure to support 21 CFR Part 11 compliant systems
* Examine how network performance can affect your validated system
* Learn how to change the network while still protecting system security

Inclusive Conference Workshop, Monday, June 23, 2003
Qualifying Computer Infrastructures for Regulatory Compliance
Including In-Depth Case Studies from:
* Aventis Pasteur-Strategies for Keeping your System in a Validated State
* Bristol-Myers Squibb-Growing a Database Qualification Program Out of Necessity
* Amgen-Understanding Configuration Management for an ERP Infrastructure

Washington, DC  
06/25/2013 - 06/26/2013 [Register]

Validation Master Planning:

Validation Master Planning Strategies from Industry Experts!
* Understand the Basic Components of a Validation Master Plan and Develop a Plan of Appropriate Detail for Specific Applications
* Define the Scope, Objectives, and Strategies for Execution of the VMP Project
* Leverage Teams and Partner Organizations Across Multiple VMPs
* Use Your VMP as a Project Management Tool that Clarifies Project Roles and Responsibilities, and Defines and Drives Project Quality
* Narrow Project Timelines by Consolidating VMP Documents and Removing Redundant and Questionable Content
* Integrate a Change Control System into Your Validation Master Plan
* Apply a Risk Assessment Approach to Computer and Software Master Planning
* Design a Comprehensive Process VMP that is Linked to Other Validation Documentation
* Meet the Challenges of Validating Software and Software-Based Instruments
* Achieve Compliance Using Utilities Validation Master Plans, Including DQ/IQ/OQ/PQ
* Implement Cleaning VMPs: Preparation, Scope, Roles and Responsibilities

In-Depth VMP Coverage for Specific Areas of Validation, Including:
* Cleaning VMPs: Preparation, Scope, Roles and Responsibilities
Syed T. Sharfuddin, Team Leader,
Technical Services, Wyeth

* Planning for a Large ERP Validation Project
Kevin C. Martin, Director, Sales & Marketing,
Systems Regulatory Compliance, CimQuest, Inc.

* Developing a Cost-Effective Validation Strategy for Utilities
John J. Vajda, Project Executive,
Building Blox Solutions

* Creating an Effective Process VMP
Rodney E. Thompson, Ph.D., Senior Consultant,
BioProcess Technology Consultants

Washington, DC  
06/27/2013 - 06/28/2013 [Register]

Micronizing and Particle Size Reduction:

* Learn how Micronization Can Affect the Polymorphic or Solvatomorphic State of a Drug Entity
* Develop Strategies to Minimize an Undesirable Drug Bioavailability Profile
* Examine Methods for Early Recognition of the Need to Micronize
* Understand the Particle Size Distribution of Drug Aerosols
* Identify Critical Milling Parameters and Current API Milling Process Technologies
* Explore a Range of Technical Solutions Presented Through Case Studies from Leading Pharmaceutical Micronization Professionals

Washington, DC  
06/29/2013 - 06/30/2013 [Register]

Electronic Signatures & Records:

* Implement Compliance Strategies to Meet the Challenges of New FDA Enforcement Approaches
* Define "Critical Systems" and the Meaning of a "Risk-Based Approach" to Systems Inspections
* Assess and Optimize Current Compliance Efforts for Electronic Records and Electronic Signatures to Meet New FDA Expectations
* Establish Compliant Legacy Systems and Bring Existing Systems into FDA Compliance
* Implement Strategies for Record Archiving and Establish Archiving Systems in Compliance with New FDA Initiatives

Learn Practical Approaches to Audits and Inspections from Two Former FDA Officials
* Gary L. Green, Principal, Cap Gemini Ernst & Young
Former Director of Strategic Systemsand Director for Research Information
US Food and Drug Administration

* A. Samuel Clark, Senior Consultant, KMI/PAREXEL
Former National Computer Expert
US Food and Drug Administration

Washington, DC  
07/05/2013 - 07/06/2013 [Register]

Strategies for Improving Solubility:

Featuring Case Studies and In-Depth Sessions:
* Measuring Solubility in the Integrated Discovery/Development Environment
* Automating the Analysis of Kinetic Solubility Data
* Examining Solubility Profiles that Are Relevant to Drug Discovery and Development
* Overview of Documentation Requirements and Regulatory Expectations for Solubility
* The Influences of Solubility and Dosing Vehicle on Oral Absorption
* Analyzing Solubility Characterization of Polymorphic and Solvatomorphic Systems

- In-Depth Pre-Conference Workshop, Thursday, June 26, 2003 -
Examining Solubility in the Design of Combinatorial Libraries
Christopher A. Lipinski, Ph.D.,
Adjunct Senior Research Fellow (retired),
Pfizer Global Research and Development Groton Laboratories

Plus In-Depth Sessions On:
* Techniques for Improving Solubility:
Determining Fast and Good-Quality Solubility Measurements in Hits-to-Leads Applications and Supercritical Fluid Processing
* Crystallization as it Applies to Solubility:
Crystal Engineering of the Composition of Pharmaceutical Phases and Crystal Modification

Washington, DC  
07/08/2013 - 07/09/2013 [Register]

Pharmaceutical Excipients:

Understanding USP, EP and JP Standards and Harmonization
* Understanding the USP-NF Perspective & Update on the Harmonization of Pharmaceutical Excipients
* Validating Compendia Method Equivalence
* Strategies for Harmonization of Excipient Testing Across Compendia
* Harmonization of Excipient Testing Processes in a Global Pharmaceutical R&D Environment
* Learn Strategies for Compendia & Functionality Testing for Formulation Development
* Develop an Excipients Dossier and Identify Documentation Requirements for Testing
* Explore Specification Development Based on Supplier Capability & User Requirements
* Examine Regulatory and Functionality Issues in Excipient Qualification
* Establishing Criteria for Qualification of Alternate Suppliers and Vendors

Washington, DC  
07/10/2013 - 07/11/2013 [Register]

Electronic Laboratory Notebooks:

* Comprehend FDA's Shift Towards Risk-Based Applications of 21 CFR Part 11 and How It Will Affect Electronic Records
* Assess Changes to Workflow & Productivity and Quantify the Return on Investment
* Build "Quality Electronic Records Programs" from Available Pieces: Products, Systems, Technologies, and Standards
* Design Comprehensive ELN Architectures and Collaborative eR&D Systems
* Set Electronic Notebook Standards and Policies and Guarantee Data Integrity and Security
* Integrate Electronic Record Keeping Systems with Other R&D and Corporate Software Systems
* Overcome Cultural Issues in Implementing an Electronic Laboratory Notebook

Clarifying the Legal and Patent Protection Issues Surrounding Electronic Laboratory Notebooks
In-depth Review and Discussion of Legal Concerns and Constraints Regarding the Creation of Electronic Records and Their Use in Legal Proceedings

Washington, DC  
07/12/2013 - 07/13/2013 [Register]

Understanding the Impact of HIPAA on Research:

* Know What New Responsibilities HIPAA Imposes on Sponsors, Clinical Researchers and CROs
* Understand the Impact of the HIPAA Security Rule on Research
* Know the Impact on the Handling of Patient Data and on the Use of Existing Databases
* Understand the Security Challenges Posed by HIPAA and Perform a Security Risk Assessment to Assess Your Data Protection Needs
* Understand Federal Standards and Practical Strategies for the De-Identification of Research Data
* Know Required Changes to the IRB Process and How HIPAA Impacts Patient Recruitment, Identification and Pre-Screening

Hear an Update on the Final Rule from the Office for Science Policy and Planning National Institutes of Health (NIH)
In-Depth Technical Coverage on:
* Understanding the Impact of HIPAA on IRBs and Informed Consent
* Implement Compliant Patient Recruitment Strategies

Plus In-depth Coverage and Strategies for:
HIPAA Compliance Solutions
Implementing Practical Approaches for Achieving HIPAA-Privacy and Security Compliance

Washington, DC  
07/14/2013 - 07/15/2013 [Register]

HVAC Systems Design
Washington, DC  

07/16/2013 - 07/17/2013 [Register]

Lyophilization
Washington, DC  

07/18/2013 - 07/19/2013 [Register]

Network Infrastructure Qualification & Systems Validation
Bethesda, MD  

07/20/2013 - 07/21/2013 [Register]

Rapid Methods
Bethesda, MD  

07/22/2013 - 07/23/2013 [Register]

Containment of Potent Compounds
Bethesda, MD  

09/02/2013 - 09/03/2013 [Register]

Environmental Monitoring
Bethesda, MD  

09/04/2013 - 09/05/2013 [Register]

Combination Products:

Gain Regulatory Approval While Overcoming Manufacturing and Quality Challenges

Proven Strategies from Industry Companies that Overcame the Obstacles

Cost-Effective Strategies for Speeding Products to Market:
* Preventing Approval Delays by Addressing Past Problems with Proven Solutions
* Overcoming Pre-Clinical Challenges and Assuring Compliance with Product Testing Requirements
* Hurdling Barriers Associated with Clinical Trials to Prevent Clinical Holds
* Developing Licensing and Collaboration Strategies for Compliance and Market Exclusivity Issues
* Employing Strategies Based on Current Regulatory Trends and Evolving Changes

Avoid Costly Delays with Leading Experts' Collective Approval Experiences

Regulatory and Industry Perspectives Provide In-Depth Coverage of:
Domestic and International Pathways for Each Type of Combination Product
* Strategies for Ensuring Desired Center Jurisdiction
* Application Strategies and Tools to Expedite Requests for Designation (RFDs)

Including Interactive Panel Discussions and Workshops
* Assessing US & International Regulatory Schemes and Exercises with Diverse Hypothetical Products Examining Product Development from A (RFD) to Z (Labeling)
* Ensuring US & International GxP Compliance; Changing Corporate Culture and Quality Infrastructure to Comply with Complex Manufacturing and Quality Expectations; and Meeting Pre-Clinical, Clinical Trial, and Product Testing Requirements

-- Featuring --
Regulatory Insights from Former FDA Reviewers with
Cell and Tissue-Based, Drug/Device, Cardiovascular Stent, and Drug Delivery Product Experience

Washington, DC  
09/06/2013 - 09/07/2013 [Register]

Bar Coding:

Developing a Comprehensive Implementation Strategy for Bar Coding

Industry Experts Share Valuable Bar-Coding Knowledge
* Abbott Laboratories
* Uniform Code Council
* Baxter Healthcare
* Karen Longe & Associates
* Pfizer
* Zebra Technologies
* LScan Technologies, Inc.
* Electronic Imaging Materials
* SciRegs Consulting
* Healthcare Compliance Packaging Council

* Learn About the New Reduced Space Symbology (RSS) and its Applications
* Understand the Benefits of HUDs and Unit-of-Use Packaging Formats
* Know How to Leverage the Supply Chain, ERP and CRM Benefits
* Strategies for Using Portable Terminals to Facilitate Tracking Bar Codes
* Understand How RFID Can Increase Pharmaceutical Supply Chain Efficiencies

Gain Valuable Insight from Real Implementation Case Studies!
Baxter Introduces a Next Generation,
High Resolution Bar Code Technology for Flexible IV Bags
Abbott Laboratories: A Case Study in Bar Coding

Hear Directly from the Uniform Code Council
Reducing Medication Errors:
* Understand the FDA Proposed Rule and the EAN.UCC Standard;
* Applications of New Bar Codes and Standard Product Identification in Healthcare

Washington, DC  
09/29/2013 - 09/30/2013 [Register]

Maintenance Compliance and Validation:

* Incorporating FDA Regulatory Compliance into Maintenance and Calibration Systems
* Implementing Solutions and Strategies for Streamlining Work Order Control
* Developing User and Agency Friendly Maintenance, Calibration and Validation Documents
* Reviewing Risk Analysis Methodology for Compliance and Validation
* Maintaining Validation in Accordance with GMP Regulations
* Ensuring Regulatory Compliance - Proactive Approach to Interactions with the FDA

In-Depth Sessions on Qualifying and Validating:
Calibration Management Programs
High Purity Water Systems
Building Management Systems
Facility and Process HVAC Systems

Bethesda, MD  
09/31/2013 - 10/01/2013 [Register]

Data Security:

Data Security Best Practices from Pharmaceutical Industry Experts!
* Incorporate 21 CFR Part 11 Data Security Compliance into Your Overall Data Security Strategy
* Implement Approaches to HIPAA Administrative, Technical and Physical Data Security Standards
* Employ Real-World Encryption Strategies and Avoid Encryption Requirements
* Secure Clinical Data within a Web-Based Electronic Data Capture (EDC) System
* Verify the Authenticity of Digital Signatures as well as the Integrity of the Data
* Determine Appropriate Levels and Technologies for Authentication and Access Controls
* Establish Backup and Disaster Recovery Plans
* Establish Methods of Effective Data Security Training Across the Organization
* Understand the Role that Risk Analysis and Risk Management Plays in HIPAA Security Compliance
* Learn the Tools and Methods Necessary to Mitigate Risks in the Wireless Network
* Explore Technology Solutions for Implementing Security with Medical Messaging Systems, Including XML Environments
* Utilize the HIPAA Guidelines as a Security Foundation for Non-Covered Entities

In-Depth Technical and Regulatory Sessions, Including:
Ensuring Your Data Security: Common Best Practices for Part 11 and HIPAA Compliance
Jacob Vishnevsky, Systems Development
Manager, Stelex-TVG

Assuring Clinical Data Security in a Web-Based EDC Environment
Phillip Quarles, President and CIO,
LifeTree Technology, LLC

Understanding and Implementing Security Principles of the EU Safe Harbor
Robyn A. Meinhardt, RN, JD, Partner,
Foley & Lardner

Achieving Data Security for Part 11 Compliance
Brian M. Wyatt, Esq., Associate,
Health Care Group, Ropes & Gray LLP

Bethesda, MD  
10/02/2013 - 10/03/2013 [Register]

Disinfectants for Pharmaceutical Manufacturing
Bethesda, MD  

10/04/2013 - 10/05/2013 [Register]

Emerging Cancer Therapeutics
Bethesda, MD  

10/06/2013 - 10/07/2013 [Register]

Extractables and Bleachable:
Bethesda, MD  

10/15/2013 - 10/16/2013 [Register]

Process Analytical Technologies:

Validation, Data Management and Chemometrics for Process Analytical Technologies:
Complying with Evolving Risk-Based Part 11 and GMPs Guidelines

Bethesda, MD  
10/22/2013 - 10/23/2013 [Register]

Environmental Monitoring:

Develop Practical Approaches for Trending Data,
Handling Investigations and Achieving FDA Compliance

Bethesda, MD  
10/24/2013 - 10/25/2013 [Register]
 
 
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