Biopharmaceutical & Pharmaceutical Training & Technology, Medical Device & Biotech Training - CfPIE
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Courses by Date

Click on one of links below to find the Biotech, Medical Device, Skin/Cosmetic or Pharmaceutical training course that best fits your schedule.
February, 2010
 
Feb. 10 - 12, 2010QA/QC Strategy for Biologics and Biopharmaceuticals
Feb. 11 & 12, 2010Adverse Drug Events – Reporting & Regulatory Requirements
Feb. 18 & 19, 2010Effective Laboratory Safety Management
Feb. 22 & 23, 2010FDA Inspections: What To Expect And How To Prepare
Feb. 22 & 23, 2010Writing Effective Standard Operating Procedures and Other Process Documents
Feb. 24 & 25, 2010Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products
Feb. 24 & 25, 2010Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
Feb. 24 & 25, 2010Writing in the Regulated Environment When English Is Your Second Language
 
March, 2010
 
Mar. 01 - 03, 2010Biostatistics for Non-Statisticians
Mar. 01 & 02, 2010Good Clinical Practice for Medical Device Investigations
Mar. 02 & 03, 2010Stability Programs for Product Shelf Life – From Development to Approval
Mar. 03 - 05, 2010The Drug Development Process - From Discovery to Commercialization
Mar. 03 & 04, 2010Good Clinical Practice Auditing
Mar. 04 & 05, 2010Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
Mar. 08 - 10, 2010Good Clinical Practices (GCPs)
Mar. 08 - 10, 2010Introduction to Molecular Biology Techniques – Applications in the Biotechnology and Pharmaceutical Industries
Mar. 09 & 10, 2010How to Prepare for a Systems-based Inspection – Understanding the FDA’s Risk-based Inspections Approach and Ensuring Compliance
Mar. 09 & 10, 2010The EU Clinical Trial Directive
Mar. 10 - 12, 2010The CTD/eCTD: Building the Marketing Application Throughout Clinical Development
Mar. 11 & 12, 2010European Filing & Registration Procedures
Mar. 11 & 12, 2010Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business
Mar. 11 & 12, 2010How to Develop an Effective Complaint Handling and Post Market Surveillance and MDR Program for Devices
Mar. 15 & 16, 2010Cleanroom Microbiology for the Non-Microbiologist
Mar. 15 & 16, 2010Clinical Trial Design For Medical Devices
Mar. 15 & 16, 2010Labeling and Labeling Controls in the Medical Device Industry
Mar. 15 & 16, 2010Preparing the CMC Section for NDAs/INDs/CTDs
Mar. 15 & 16, 2010Validation of Computer Systems
Mar. 17 - 19, 2010Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
Mar. 17 & 18, 2010Purchasing Controls in the Medical Device Industry
Mar. 17 & 18, 2010Sterilization Procedures: Technology, Equipment and Validation
Mar. 22 & 23, 2010Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
Mar. 22 & 23, 2010Pharmaceutical Production Batch Record Review
Mar. 22 & 23, 2010Project Management for Phase 1 & 2 Clinical Trials
Mar. 24 - 26, 2010Optimization of Drug-Like Properties in Drug Discovery – Assessment and Structure Modification Strategies
Mar. 24 & 25, 2010Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process
Mar. 29 & 30, 2010Selecting and Managing CROs
Mar. 31 & Apr. 01, 2010Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities
 
April, 2010
 
Apr. 08 & 09, 2010Project Management for Phase 1 & 2 Clinical Trials
Apr. 08 & 09, 2010Quality System Regulation for the Medical Device & Biotech Industries
Apr. 12 - 14, 2010Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
Apr. 12 & 13, 2010Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
Apr. 12 & 13, 2010Best Practices for Facilities and Utilities Design, Qualification and Monitoring – Applying the Life-Cycle Concept
Apr. 12 & 13, 2010How to Monitor Clinical Trials for GCP Compliance
Apr. 12 & 13, 2010Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process
Apr. 14 - 16, 2010CMC Regulatory Compliance for Biopharmaceuticals and Biologics
Apr. 14 & 15, 2010Effective Qualification and Monitoring of Processing Equipment and Their Control Systems
Apr. 15 & 16, 2010Patent and Other Intellectual Property Law for the Life Sciences Industry
Apr. 15 & 16, 2010Writing Effective Standard Operating Procedures and Other Process Documents
Apr. 19 - 21, 2010Biostatistics for Non-Statisticians
Apr. 19 - 21, 2010cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
Apr. 19 - 21, 2010QA/QC Strategy for Biologics and Biopharmaceuticals
Apr. 19 & 20, 2010Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
Apr. 19 & 20, 2010Effective Quality Assurance Auditing for FDA Regulated Industries
Apr. 20 & 21, 2010Pediatric Clinical Trial Design - Ethics, Management and Regulatory Requirements
Apr. 21 - 23, 2010Process Validation for Medical Devices
Apr. 21 - 23, 2010The Drug Development Process - From Discovery to Commercialization
Apr. 22 & 23, 2010Introduction to Effective Medical Writing
Apr. 22 & 23, 2010Introduction to Statistical Analysis of Laboratory Data
Apr. 22 & 23, 2010Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
Apr. 22 & 23, 2010Pharmaceutical and Biopharmaceutical Quality Control Laboratories -  A Regulatory Compliance Primer
Apr. 26 & 27, 2010FDA Inspections of Clinical Data Systems
Apr. 26 & 27, 2010How to Implement Risk Management Principles and Activities Within a Quality Management System
Apr. 26 & 27, 2010The EU Clinical Trial Directive
Apr. 26 & 27, 2010Validation of Computer Systems
Apr. 28 & 29, 2010Dermatological Product Development
Apr. 28 & 29, 2010Essentials of Program, Project & Portfolio Management in Bio-Pharmaceutical Discovery
Apr. 28 & 29, 2010European Filing & Registration Procedures
 
May, 2010
 
May 03 - 05, 2010cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
May 04 & 05, 2010Latin America – Understanding Regulatory Compliance Requirements
May 04 & 05, 2010Software Development for Medical Device Professionals
May 06 & 07, 2010Effective Laboratory Safety Management
May 06 & 07, 2010Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
May 06 & 07, 2010Pharmaceutical and Biopharmaceutical Quality Control Laboratories -  A Regulatory Compliance Primer
May 10 & 11, 2010Good Laboratory Practices (GLP) for Pre-Clinical Testing
May 10 & 11, 2010Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
May 11 & 12, 2010Best Practices for an Effective Cleaning Validation Program
May 12 - 14, 2010Good Manufacturing Practices (cGMP)
May 13 & 14, 2010Process Validation for Drugs and Biologics
May 17 & 18, 2010Pharmaceutical Water Systems: Contemporary Technology and Compliance
May 17 & 18, 2010Practical Methods for Project Management
May 17 & 18, 2010Writing Effective Standard Operating Procedures and Other Process Documents
May 18 & 19, 2010Good Monitoring Practices for Medical Devices
May 19 - 21, 2010Root Cause Analysis for CAPA
May 19 & 20, 2010Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach
May 20 & 21, 2010Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
May 20 & 21, 2010Writing in the Regulated Environment When English Is Your Second Language
May 24 - 26, 2010ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
May 24 - 26, 2010Tablets and Capsules - Development, Manufacture and Testing of Solid Oral Dosage Forms
May 24 & 25, 2010Clinical Trial Design For Medical Devices
May 24 & 25, 2010Overview Of FDA Regulatory Compliance For Medical Devices
May 26 - 28, 2010Process Validation for Medical Devices
 
June, 2010
 
June 02 - 04, 2010CMC Regulatory Compliance for Biopharmaceuticals and Biologics
June 03 & 04, 2010Practical Methods for Project Management
June 07 - 09, 2010Good Clinical Practices (GCPs)
June 07 - 09, 2010QA/QC Strategy for Biologics and Biopharmaceuticals
June 09 - 11, 2010Reporting Failure Investigations and Process Deviations
June 10 & 11, 2010Adverse Drug Events – Reporting & Regulatory Requirements
June 10 & 11, 2010Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
June 10 & 11, 2010Detecting Fraud and Misconduct in Clinical Trials
June 14 - 16, 2010The CTD/eCTD: Building the Marketing Application Throughout Clinical Development
June 14 & 15, 2010FDA Inspections of Clinical Data Systems
June 14 & 15, 2010Overview Of FDA Regulatory Compliance For Medical Devices
June 14 & 15, 2010Preparing the CMC Section for NDAs/INDs/CTDs
June 16 & 17, 2010How to Prepare for a Systems-based Inspection – Understanding the FDA’s Risk-based Inspections Approach and Ensuring Compliance
June 17 & 18, 2010Effective Risk-Based Applications of Drug cGMPs and Validation Req. for Cosmetics and OTC Drug Prod.
June 22 & 23, 2010Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
June 22 & 23, 2010Project Management for Phase 1 & 2 Clinical Trials
June 23 - 25, 2010The Drug Development Process - From Discovery to Commercialization
June 24 & 25, 2010Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process
June 24 & 25, 2010Stability Programs for Product Shelf Life – From Development to Approval
June 28 & 29, 2010Quality System Regulation for the Medical Device & Biotech Industries
 
July, 2010
 
July 12 - 14, 2010Biostatistics for Non-Statisticians
July 12 & 13, 2010Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
July 12 & 13, 2010Introduction to Effective Medical Writing
July 12 & 13, 2010Validation of Computer Systems
July 15 & 16, 2010Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
July 19 - 21, 2010Optimization of Drug-Like Properties in Drug Discovery – Assessment and Structure Modification Strategies
July 20 & 21, 2010Design Control for Medical Device Professionals
July 22 & 23, 2010Design Validation, Verification, and Risk Analysis for Medical Device Professionals
July 22 & 23, 2010How to Monitor Clinical Trials for GCP Compliance
July 27 & 28, 2010Cleanroom Microbiology for the Non-Microbiologist
July 29 & 30, 2010Sterilization Procedures: Technology, Equipment and Validation
 


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