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Education Events
The Center for Professional Innovation & Education
7 Great Valley Parkway, Suite 128
Malvern, PA 19355
September
Sep. 8 – 10 Introduction to Molecular Biology Techniques King of Prussia, PA
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 ApproachTo Compliance King of Prussia, PA
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. 23 & 24 Stability Programs for Product Shelf Life - From Development to Approval King of Prussia, PA
Sep. 23 & 24 Best Practices for Facilities and Utilities Design, Qualification and Monitoring 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
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. 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 - 20 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 Introduction to Statistical Analysis of Laboratory Data 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
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
Dec. 1 – 3 Technical Writing for Pharmaceutical, Medical Device and Biotech Industries King of Prussia, PA
Dec. 2 & 3 Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities King of Prussia, PA
Dec. 6 – 8 cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices King of Prussia, PA
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. 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