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