Industry Events

Education Events

The Center for Professional Innovation & Education
7 Great Valley Parkway, Suite 128
Malvern, PA 19355

March, 2010

Mar. 1 & 2     Good Clinical Practice for Medical Device Investigations
 
Mar. 2 & 3     Stability Programs for Product Shelf Life - From Development to Approval  
   
Mar. 3 & 4     Good Clinical Practice Auditing
  
Mar. 8 – 10   Introduction to Molecular Biology Techniques   
 
Mar. 8 & 9     Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA  
   
Mar. 9 & 10   The EU Clinical Trial Directive  
 
 
Mar. 9 & 10   How to Prepare for a Systems-based Inspection - Understanding FDA's Risk-based Inspections Approach  
   
Mar. 10 – 12  The CTD/eCTD: Building the Marketing Application throughout Clinical Development  
  
Mar. 11 & 12  Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business  
  
Mar. 11 & 12  How to Develop an Effective Complaint Handling, and Post Market Surveillance Program for Drugs & Devices
  
Mar. 11 & 12  European Filing & Registration Procedures  
  
Mar. 15 & 16  Cleanroom Microbiology for the Non-Microbiologist  
  
Mar. 15 & 16  Labeling and Labeling Controls for Medical Devices  
  
Mar. 15 & 16  Clinical Trials Design for Medical Devices 

Mar. 17 – 19  Technical Writing for Pharmaceutical, Medical Device and Biotech Industries  
  
Mar. 17 & 18  Sterilization Procedures: Technology, Equipment & Validation  
 
Mar. 17 & 18  Purchasing Controls in the Medical Device Industry
 
Mar. 22 & 23  Project Management for Phase 1 & 2 Clinical Trials  
 
Mar. 24 & 25  Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process  
 
Mar. 29 & 30  Selecting and Managing CRO's
 
Mar. 31-Apr. 1 Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities  

April 2010

Apr. 7 – 9 Active Pharmaceutical Ingredient (API) and Drug Product Specifications,  King of Prussia, PA

Apr. 8 & 9 Quality System Regulation for the Medical Device & Biotech Industries, King of Prussia, PA
 
Apr. 12 & 13 How to Monitor Clinical Trials for GCP Compliance, King of Prussia, PA

Apr. 19 – 21 Biostatistics for Non - Statisticians, King of Prussia, PA 

Apr. 20 & 21 Pediatric Clinical Trial Design - Ethics, Management and Regulatory Requirements 
 King of Prussia, PA
 

Apr. 22 & 23 Introduction to Statistical Analysis of Laboratory Data, King of Prussia, PA 

Apr. 28 & 29 Dermatological Product Development, Malvern, PA

May 2010

May 4 & 5 Latin America - Understanding Regulatory Compliance Requirements, Malvern, PA 

May 4 & 5 Software Development for Medical Device Professionals, Malvern, PA  

May 6 & 7 Effective Laboratory Safety Management, Malvern, PA

May 6 & 7 Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences 
 Malvern, PA

May 18 & 19 Good Monitoring Practices for Medical Devices, Malvern, PA 

May 20 & 21 Medical Devices - EU Directives, Guidance, CE Marking and ISO Standard Certifications, Malvern, PA

May 24 – 26 Tablets & Capsules - Development, Manufacture and Testing of Solid Oral Dosage Forms, Malvern, PA

June 2010

June 3 & 4 Practical Methods for Project Management, King of Prussia, PA

June 9 – 11 Reporting Failure Investigations and Process Deviations, King of Prussia, PA

June 10 & 11 Detecting Fraud and Misconduct in Clinical Trials, King of Prussia, PA

June 14 & 15 Preparing the CMC Section for NDAs/CTDs/INDs, King of Prussia, PA 

June 14 & 15 Overview of FDA Regulatory Compliance for Medical Devices, King of Prussia, PA 

June 16 & 17 How to Prepare for a Systems-based Inspection - Understanding FDA's Risk-based Inspections Approach, King of Prussia, PA

June 17 & 18 Effective Risk-Based Applications of Drug cGMPs and Validation Requirements for Cosmetics and OTC Drug Products, King of Prussia, PA

June 23 – 25 The Drug Development Process - From Discovery to Commercialization 
 King of Prussia, PA