Sep. 08 - 10, 2010
 Introduction to Molecular Biology Techniques – Applications in the Biotechnology and Pharmaceutical Industries
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Sep. 15 - 17, 2010
ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
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Sep. 15 & 16, 2010
Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business
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Sep. 15 & 16, 2010
Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
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Sep. 20 & 21, 2010
Clinical Document Management - A Trial-by-Trial Approach to Compliance
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Sep. 21 & 22, 2010
Introduction to Medical Device Submissions – 510ks, PMAs, and Exemptions
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Sep. 21 & 22, 2010
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
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Sep. 23 & 24, 2010
Best Practices for Facilities and Utilities Design, Qualification and Monitoring – Applying the Life-Cycle Concept
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Sep. 23 & 24, 2010
Introduction to Medical Combination Products
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Sep. 23 & 24, 2010
Stability Programs for Product Shelf Life – From Development to Approval
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Sep. 27 & 28, 2010
Best Practices for an Effective Cleaning Validation Program
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Sep. 27 & 28, 2010
Good Laboratory Practices (GLP) for Pre-Clinical Testing
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Sep. 28 & 29, 2010
The EU Clinical Trial Directive
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Sep. 29 - Oct. 1, 2010
Good Manufacturing Practices (cGMP)
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Sep. 29 & 30, 2010
Process Validation for Drugs and Biologics
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Sep. 30 & Oct. 01, 2010
European Filing & Registration Procedures
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Oct. 04 & 05, 2010
Patent and Other Intellectual Property Law for the Life Sciences Industry
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Oct. 04 & 05, 2010
Practical Methods for Project Management
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Oct. 05 & 06, 2010
Effective Quality Assurance Auditing for FDA Regulated Industries
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Oct. 07 & 08, 2010
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
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Oct. 07 & 08, 2010
How to Implement Risk Management Principles and Activities Within a Quality Management System
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Oct. 07 & 08, 2010
Quality System Regulation for the Medical Device & Biotech Industries
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Oct. 11 & 12, 2010
FDA Inspections: What To Expect And How To Prepare
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Oct. 11 & 12, 2010
How to Monitor Clinical Trials for GCP Compliance
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Oct. 12 & 13, 2010
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
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Oct. 13 - 15, 2010
Process Validation for Medical Devices
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Oct. 13 - 15, 2010
QA/QC Strategy for Biologics and Biopharmaceuticals
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Oct. 13 & 14, 2010
Detecting Fraud and Misconduct in Clinical Trials
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Oct. 14 & 15, 2010
Pharmaceutical Production Batch Record Review
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Oct. 18 - 20, 2010
Biostatistics for Non-Statisticians
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Oct. 18 & 19, 2010
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
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Oct. 20 - 22, 2010
CMC Regulatory Compliance for Biopharmaceuticals and Biologics
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Oct. 21 & 22, 2010
Essentials of Program, Project & Portfolio Management in Bio-Pharmaceutical Discovery
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Oct. 21 & 22, 2010
Introduction to Statistical Analysis of Laboratory Data
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Oct. 25 & 26, 2010
Design Control for Medical Device Professionals
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Oct. 25 & 26, 2010
Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
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Oct. 27 & 28, 2010
Design Validation, Verification, and Risk Analysis for Medical Device Professionals
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Oct. 28 & 29, 2010
FDA Inspections of Clinical Data Systems
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Oct. 28 & 29, 2010
Introduction to Effective Medical Writing
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Nov. 01 & 02, 2010
Project Management for Phase 1 & 2 Clinical Trials
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Nov. 03 - 05, 2010
Spectroscopic Method Development for the Pharmaceutical & Biotech Industries
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Nov. 03 & 04, 2010
Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process
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Nov. 04 & 05, 2010
Effective Laboratory Safety Management
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Nov. 08 & 09, 2010
Cleanroom Microbiology for the Non-Microbiologist
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Nov. 10 - 12, 2010
The Drug Development Process - From Discovery to Commercialization
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Nov. 10 & 11, 2010
Sterilization Procedures: Technology, Equipment and Validation
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Nov. 11 & 12, 2010
Preparing the CMC Section for NDAs/INDs/CTDs
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Nov. 15 - 17, 2010
Good Clinical Practices (GCPs)
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Nov. 15 & 16, 2010
Latin America – Understanding Regulatory Compliance Requirements
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Nov. 16 & 17, 2010
Pharmaceutical Water Systems: Contemporary Technology and Compliance
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Nov. 17 & 18, 2010
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
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Nov. 18 & 19, 2010
Effective Risk-Based Applications of Drug cGMPs and Validation Req. for Cosmetics and OTC Drug Prod.
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Nov. 30 & Dec. 01, 2010
Selecting and Managing CROs
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Dec. 01 - 03, 2010
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
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Dec. 02 & 03, 2010
Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities
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Dec. 06 - 08, 2010
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
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Dec. 06 & 07, 2010
Validation of Computer Systems
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Dec. 13 & 14, 2010
Good Clinical Practice for Medical Device Investigations
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Dec. 15 & 16, 2010
Good Clinical Practice Auditing
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