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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:

 

February 2012
 

Feb. 6 & 7
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products  King of Prussia, PA
 

Feb. 6 – 8
Good Clinical Practices (GCPs)  King of Prussia, PA
 

Feb. 6 & 7
Practical Methods for Project Management  Los Angeles, CA
 

Feb. 8 – 10
QA/QC Strategy for Biologics and Biopharmaceuticals  King of Prussia, PA
 

Feb. 9 & 10
Adverse Drug Events – Reporting and Regulatory Requirements  King of Prussia, PA
 

Feb. 9 & 10
Effective Laboratory Safety Management  Los Angeles, CA
 

Feb. 13 & 14
Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products  King of Prussia, PA
 

Feb. 14 & 15
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices  King of Prussia, PA
 

Feb. 15 & 16
FDA Inspections -What Regulators Expect and How to Prepare  King of Prussia, PA
 

Feb. 27 - 29
Biostatistics for Non-Statisticians  King of Prussia, PA
 

Feb. 27 - 29
Lyophilization Technology - Practical Application of the Scientific Principles  King of Prussia, PA
 


March 2012

 

Mar. 1 & 2
Clinical Document Management - A Trial by Trial Approach to Compliance  Los Angeles, CA
 

Mar. 1 & 2
Introduction to Statistical Analysis of Laboratory Data  King of Prussia, PA
 

Mar. 5 & 6
Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, ABLAs, Post-Approval Supplements)  King of Prussia, PA
 

Mar. 5 & 6
Cleanroom Microbiology for the Non-Microbiologist  King of Prussia, PA
 

Mar. 5 – 7
Introduction to Molecular Biology Techniques - Applications in the Biotechnology and Pharmaceutical Industries  King of Prussia, PA
 

Mar. 5 & 6
Introduction to Medical Combination Products  Los Angeles, CA
 

Mar. 7 & 8
Introduction to Medical Device Submissions - 510ks, PMAs, and Exemptions  Los Angeles, CA
 

Mar. 7 & 8
Sterilization Procedures Technology, Equipment & Validation  King of Prussia, PA
 

Mar. 8 & 9
Validation of Computer Systems  King of Prussia, PA
 

Mar. 12 & 13
Design Control for Medical Device Professionals  Los Angeles, CA
 

Mar. 14 & 15
Design Validation, Verification, and Risk Analysis for Medical Device Professionals  Los Angeles, CA
 

Mar. 15 & 16
Preparing the CMC Section for NDAs/INDs/CTDs  Los Angeles, CA
 

Mar. 19 & 20
Selecting and Managing CROs  Los Angeles, CA
 

Mar. 22 & 23
Writing Effective Standard Operating Procedures and Other Process Documents  King of Prussia, PA
 

Mar. 26 & 27
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products  Los Angeles, CA
 

Mar. 26 & 27
Writing in the Regulated Environment When English Is Your Second Language  King of Prussia, PA
 

Mar. 26 & 27
Pharmaceutical Production Batch Record Review  Los Angeles, CA
 

Mar. 26 & 27
Project Management for Phase 1 & 2 Clinical Trials  King of Prussia, PA
 

Mar. 28 & 29
Project Management for Phase 3 and LCM (Life Cycle Management) of the Drug Development Process  King of Prussia, PA
 

Mar. 28 – 30
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries  King of Prussia, PA
 

April 2012
 

April 2 & 3
How to Monitor Pharmaceutical, Biologic and Medical Device Clinical Trials for GCP Compliance  King of Prussia, PA
 

April 2 & 3
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences  Los Angeles, CA
 

April 2 & 3
Quality System Regulation for the Medical Device & Biotech Industries  King of Prussia, PA
 

April 4 & 5
GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials  King of Prussia, PA
 

April 23 – 25
Active Pharmaceutical Ingredient (API) and Drug Product Specifications  King of Prussia, PA
 

April 23 – 25
Process Validation for Medical Devices  Los Angeles, CA
 

April 26 & 27
How to Implement Risk Management Principles and Activities within a Quality Management System  Los Angeles, CA
 

April 26 & 27
Stability Programs for Product Shelf Life - From Development to Approval  King of Prussia, PA
 

May 2012
 

May 1 & 2
Best Practices For An Effective Cleaning Validation Program  Los Angeles, CA
 

May 2 – 4
Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy  King of Prussia, PA
 

May 3 & 4
Process Validation for Drugs and Biologics  Los Angeles, CA
 

May 14 – 16
The Drug Development Process - From Discovery to Commercialization  Los Angeles, CA
 

May 15 & 16
Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries  Los Angeles, CA
 

May 16 - 18
ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development  Los Angeles, CA
 

May 17 & 18
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach  Los Angeles, CA
 

May 21 & 22
The EU Clinical Trial Directive  King of Prussia, PA
 

May 21 & 22
Writing Effective Standard Operating Procedures and Other Process Documents  Los Angeles, CA
 

May 23 & 24
Effective Document Management for the Pharmaceutical, Biotech and Medical Device Industries  Los Angeles, CA
 

June 2012
 

June 4 – 6
Good Clinical Practices (GCPs)  Los Angeles, CA
 

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

June 7 & 8
Adverse Drug Events – Understanding and Reporting Requirements  Los Angeles, CA
 

June 11 & 12
The Electronic Common Technical Document (eCTD) - Building Comprehensive Functionality for Effective Implementation  King of Prussia, PA
 

June 11 & 12
Validation of Computer Systems  Los Angeles, CA
 

June 11 & 12
Analytical Method Validation for Biologics, Biopharmaceuticals and other Therapeutic Products  Los Angeles, CA
 

June 12 & 13
FDA Inspections -What Regulators Expect and How to Prepare  Los Angeles, CA
 

June 13 – 15
QA/QC Strategy for Biopharmaceuticals and Biologics  Los Angeles, CA
 

June 18 & 19
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA  Los Angeles, CA
 

June 19 & 20
Comprehensive Overview of FDA Regulatory Compliance for Medical Devices  King of Prussia, PA
 

June 20 – 22
CMC Regulatory Compliance for Biopharmaceuticals and Biologics  Los Angeles, CA
 

June 25 - 27
Lyophilization Technology - Practical Application of the Scientific Principles  Los Angeles, CA
 

June 25 & 26
Project Management for Phase 1 & 2 Clinical Trials  Los Angeles, CA
 

June 25 & 26
Preparing the CMC Section for NDAs-CTDs-INDs  King of Prussia, PA
 

June 27 & 28
Project Management for Phase 3 and LCM (Life Cycle Management) of the Drug Development Process  Los Angeles, CA
 
 

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Courses offered in Europe:

 

March 2012
 

Mar. 14 – 16
The Drug Development Process - From Discovery to Commercialization  Berlin, Germany
 

Mar. 19 – 21
Good Clinical Practices (GCPs)  Berlin, Germany
 

Mar. 19 – 21
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices  Dublin, Ireland
 

Mar. 20 – 22
Lyophilization Technology - Practical Application of the Scientific Principles  Dublin, Ireland
 

Mar. 26 & 27
Process Validation for Drugs and Biologics  Dublin, Ireland
 

Mar. 28 & 29
Comprehensive Overview of FDA Regulatory Compliance for Medical Devices  Dublin, Ireland
 

Mar. 29 & 30
EU Filing and Registration Procedures  Dublin, Ireland
 

April 2012
 

April 12 & 13
Development and Validation of Bioanalytical Assays for Biologics: Quantification (PK) and Immunogenicity Assays  Berlin, Germany
 

April 19 & 20
Effective Document Management for the Pharmaceutical, Biotech and Medical Device Industries  Berlin, Germany
 

April 23 & 24
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products  Berlin, Germany
 

April 23 – 25
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries  Berlin, Germany
 

April 25 – 27
QA/QC Strategy for Biopharmaceuticals and Biologics  Berlin, Germany
 

April 26 & 27
Writing Effective Standard Operating Procedures and Other Process Documents  Berlin, Germany
 

May 2012
 

May 7 & 8
Validation of Computer Systems  Berlin, Germany
 

May 14 & 15
Medical Devices – EU Directives Guidance CE Marking and ISO Standard Certifications  Dublin, Ireland
 

May 16 & 17
Practical Methods for Project Management  Dublin, Ireland
 

May 17 & 18
Medical Devices – Developing Effective Post Market Surveillance and Complaint Handling Systems  Dublin, Ireland
 

May 21 & 22
Medical Devices – Field Actions and Their Management - Recalls, Product Recovery, Safety Alert  Dublin, Ireland
 

May 21 & 22
FDA Inspections -What Regulators Expect and How to Prepare  Dublin, Ireland
 
 

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