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

 

CfPIE's Training Courses: Course Schedule -- USA Course Schedule -- Europe         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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