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CfPIE (The Center for Professional Innovation & Education Corp.)
Training Courses
 

 
CfPIE's Training Courses:

      Website:  Pharmaceutical, Biotech and Medical Device Training from CfPIE



Courses offered in the United States:

 

September 2010
 

Sep, 8 – 10
Technical Writing for Pharmaceutical, Medical Device and Biotech Industries  Costa Mesa, CA
 

Sep, 8 – 10
Introduction to Molecular Biology Techniques  King of Prussia, PA
 

Sep, 9 & 10
Preparing the CMC Section for NDAs/CTDs/INDs  Costa Mesa, CA
 

Sep, 13 & 14
Good Monitoring Practices for Medical Devices  Costa Mesa, CA
 

Sep, 15 & 16
Medical Devices - EU Directives, Guidance, CE Marking and ISO Standard Certifications  Costa Mesa, CA
 

Sep, 15 & 16
Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business  King of Prussia, PA
 

Sep, 15 – 17
ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development  King of Prussia, PA
 

Sep. 20 & 21
Clinical Document Management – A Trial by Trial Approach To Compliance  King of Prussia, PA
 

Sep, 20 & 21
Labeling and Labeling Controls for Medical Devices  Costa Mesa, CA
 

Sep. 21 & 22
Introduction to Medical Device Submissions – 510ks, PMAs, and Exemptions  King of Prussia, PA
 

Sep, 21 & 22
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA  King of Prussia, PA
 

Sep, 22 & 23
Software Development for Medical Device Professionals  Costa Mesa, CA
 

Sep, 22 & 23
Purchasing Controls in the Medical Device Industry  Costa Mesa, CA
 

Sep, 23 & 24
Stability Programs for Product Shelf Life - From Development to Approval  King of Prussia, PA
 

Sep. 23 & 24
Introduction to Medical Combination Products  King of Prussia. PA
 

Sep, 27 & 28
Good Laboratory Practices (GLP) for Pre-Clinical Testing  King of Prussia, PA
 

Sep, 27 & 28
Best Practices for an Effective Cleaning Validation Program  King of Prussia, PA
 

Sep, 28 & 29
The EU Clinical Trial Directive  King of Prussia, PA
 

Sep, 29 – Oct, 1
Good Manufacturing Practices  King of Prussia, PA
 

Sep, 29 & 30
Process Validation for Drugs and Biologics  King of Prussia, PA
 

Sep, 30 & Oct, 1
European Filing & Registration Procedures  King of Prussia, PA
 


October 2010
 

Oct. 4 & 5
Practical Methods for Project Management  King of Prussia, PA
 

Oct. 4 & 5
Patent and Other Intellectual Property Law for the Life Sciences Industry  King of Prussia, PA
 

Oct. 4 - 6
Tablets & Capsules - Development, Manufacture and Testing of Solid Oral Dosage Forms  Costa Mesa, CA
 

Oct. 4 & 5
Validation of Computer Systems  Costa Mesa, CA
 

Oct. 5 & 6
Effective Quality Assurance Auditing for FDA Regulated Industries  King of Prussia, PA
 

Oct. 7 & 8
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products  King of Prussia, PA
 

Oct. 7 & 8
How to Implement Risk Management Principles and Activities within a Quality Management System  King of Prussia, PA
 

Oct. 7 & 8
Quality System Regulation for the Medical Device & Biotech Industries  King of Prussia, PA
 

Oct. 11 & 12
FDA Inspections - What to Expect and How to Prepare  King of Prussia, PA
 

Oct. 11 & 12
How to Monitor Clinical Trials for GCP Compliance  King of Prussia, PA
 

Oct. 12 & 13
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices  King of Prussia, PA
 

Oct. 13 & 14
Detecting Fraud & Misconduct in Clinical Trials  King of Prussia, PA
 

Oct. 13 - 15
Process Validation for Medical Devices  King of Prussia, PA
 

Oct. 13 – 15
QA/QC Strategy for Biopharmaceuticals and Biologics  King of Prussia, PA
 

Oct. 14 & 15
Pharmaceutical Production Batch Record Review  King of Prussia, PA
 

Oct. 18 & 19
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products  King of Prussia, PA
 

Oct. 18 & 19
Introduction to Statistical Analysis of Laboratory Data  King of Prussia, PA
 

Oct. 20 - 22
Biostatistics for Non-Statisticians  King of Prussia, PA
 

Oct. 20 – 22
CMC Regulatory Compliance for Biopharmaceuticals and Biologics  King of Prussia, PA
 

Oct. 21 & 22
Essentials of Program, Project & Portfolio Management in Bio/Pharmaceutical Discovery  King of Prussia, PA
 

Oct. 25 & 26
Design Control for Medical Device Professionals  King of Prussia, PA
 

Oct. 25 & 26
Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries  King of Prussia, PA
 

Oct. 26 & 27
Pediatric Clinical Trial Design - Ethics, Management and Regulatory Requirements  King of Prussia, PA
 

Oct. 27 & 28
Design Validation, Verification, and Risk Analysis for Medical Device Professionals  King of Prussia, PA
 

Oct. 28 & 29
FDA Inspections of Clinical Data Systems  King of Prussia, PA
 

Oct. 28 & 29
Introduction to Effective Medical Writing  King of Prussia, PA
 


November 2010
 

Nov. 1 & 2
Project Management for Phase 1 & 2 Clinical Trials  King of Prussia, PA
 

Nov. 3 – 5
Optimization of Drug-Like Properties in Drug Discovery – Assessment And Structure Modification Strategies  King of Prussia, PA
 

Nov. 3 & 4
Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process  King of Prussia, PA
 

Nov. 3 – 5
Spectroscopic Method Development for the Pharmaceutical and Biotech Industries  King of Prussia, PA
 

Nov. 4 & 5
Effective Laboratory Safety Management  King of Prussia, PA
 

Nov. 8 & 9
Cleanroom Microbiology for the Non-Microbiologist  King of Prussia, PA
 

Nov. 10 – 12
The Drug Development Process – From Discovery to Commercialization  King of Prussia, PA
 

Nov. 10 & 11
Sterilization Procedures: Technology, Equipment & Validation  King of Prussia, PA
 


Nov. 11 & 12
Preparing the CMC Section for NDAs/CTDs/INDs  King of Prussia, PA
 


Nov. 15 – 17
Good Clinical Practices (GCP)  King of Prussia, PA
 

Nov. 15 & 16
Latin America - Understanding Regulatory Compliance Requirements  King of Prussia, PA
 

Nov. 16 & 17
Pharmaceutical Water Systems: Contemporary Technology & Compliance  King of Prussia, PA
 

Nov. 17 & 18
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences  King of Prussia, PA
 

Nov. 18 & 19
Effective Risk-Based Applications of Drug cGMPs and Validation Requirements for Cosmetics and OTC Drug Products  King of Prussia, PA
 

Nov. 30 & Dec. 1
Selecting and Managing CRO's  King of Prussia, PA
 


December 2010
 

Dec. 1 – 3
Good Manufacturing Practices  Costa Mesa, CA
 

Dec. 1 – 3
Technical Writing for Pharmaceutical, Medical Device and Biotech Industries  King of Prussia, PA
 

Dec. 2 & 3
Clinical Trial Design for Medical Devices  Costa Mesa, CA
 

Dec. 2 & 3
Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities  King of Prussia, PA
 

Dec. 2 & 3
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA  Costa Mesa, CA
 

Dec. 6 – 8
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices  King of Prussia, PA
 

Dec. 6 & 7
Stability Programs for Product Shelf Life - From Development to Approval  Costa Mesa, CA
 

Dec. 8 – 10
Root Cause Analysis for CAPA  King of Prussia, PA
 

Dec. 8 & 9
Software Development for Medical Device Professionals  King of Prussia, PA
 

Dec. 8 – 10
The CTD/eCTD: Building the Marketing Application throughout Clinical Development  Costa Mesa, CA
 

Dec. 13 & 14
Good Clinical Practice for Medical Device Investigations  King of Prussia, PA
 

Dec. 13 & 14
Overview of FDA Regulatory Compliance for Medical Devices  King of Prussia, PA
 

Dec. 15 & 16
Good Clinical Practice Auditing  King of Prussia, PA
 
 

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Courses offered in Europe:
 

September 2010
 

Sep, 16 & 17
Pharmaceutical Production Batch Record Review  Berlin, Germany
 

Sep, 16 & 17
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products  Dublin, Ireland
 
 
Sep, 20 - 22
CMC Regulatory Compliance for Biopharmaceuticals and Biologics  Dublin, Ireland
 
 
Sep, 20 & 21
Validation of Computer Systems  Dublin, Ireland
 
 
Sep, 27 & 28
Adverse Drug Events – Reporting & Regulatory Requirements  Dublin, Ireland
 
 
Sep, 27 & 28
Design Control for Medical Device Professionals  Dublin, Ireland
 
 
Sep, 29 – Oct, 1
The Drug Development Process - From Discovery to Commercialization  Dublin, Ireland
 
 
Sep, 29 & 30
Design Validation, Verification, and Risk Analysis for Medical Device Professionals  Dublin, Ireland
 


October 2010
 

Oct. 5 & 6
The EU Clinical Trial Directive  Dublin, Ireland
 

Oct. 7 & 8
European Filing & Registration Procedures  Dublin, Ireland
 

Oct. 11 & 12
Medical Devices - EU Directives, Guidance, CE Marking and ISO Standard Certifications  Dublin, Ireland
 

Oct. 21 & 22
Auditing and Qualifying Suppliers and Vendors  Berlin, Germany
 

Oct. 25 & 26
Best Practices for an Effective Cleaning Validation Program  Berlin, Germany
 

Oct. 27 & 28
Process Validation for Drugs and Biologics  Berlin, Germany
 


November 2010
 

Nov. 2 & 3
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA  Berlin, Germany
 

Nov. 2 & 3
Selecting and Managing CRO's  Berlin, Germany
 

Nov. 4 & 5
Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities  Berlin, Germany
 

Nov. 4 & 5
Stability Programs for Product Shelf Life - From Development to Approval  Berlin, Germany
 

Nov. 10 – 12
The CTD/eCTD: Building the Marketing Application throughout Clinical Development   Dublin, Ireland
 
 

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