Sponsoring Members:
Education Opportunities
The Center for Professional Innovation & Education
7 Great Valley Parkway, Suite 128
Malvern, PA
April
Apr. 8 – 10 cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
King of Prussia, PA
Apr. 11 & 12 Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer
King of Prussia, PA
Apr. 15 – 17 Active Pharmaceutical Ingredient (API) and Drug Product Specifications
King of Prussia, PA
Apr. 18 & 19 Good Laboratory Practices for Pre-Clinical Testing
King of Prussia, PA
Apr. 18 & 19 Stability Programs for Product Shelf Life - From Development to Approval
King of Prussia, PA
Apr. 29 & 30 Introduction to Effective Medical Writing
King of Prussia, PA
MAY
May 9 & 10 Effective Document Management for the Pharmaceutical, Biotech and Medical Device Industries
King of Prussia, PA
June
June 10 & 11 Pediatric Clinical Trial Design
King of Prussia, PA
June 12 & 13 Clinical Trial Design for Medical Devices
King of Prussia, PA
June 24 & 25 Preparing the CMC Section for NDAs-CTDs-INDs
King of Prussia, PA
July
July 15 & 16 Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
King of Prussia, PA
July 15 & 16 Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
King of Prussia, PA
July 18 & 19 Medical Devices - Developing Effective Post Market Surveillance and Complaint Handling Systems
King of Prussia, PA
July 25 & 26 Navigating Latin American Regulatory Compliance Requirements for Clinical Trials
King of Prussia, PA
August
Aug. 1 & 2 Development and Validation of Bioanalytical Assays for Biologics: Quantification (PK) and Immunogenicity Assays
King of Prussia, PA
Aug. 1 & 2 Comprehensive Overview of European Regulatory Procedures - EU and Member State Submission Requirements
King of Prussia, PA
Aug. 12 & 13 The Electronic Common Technical Document (eCTD) - Building Comprehensive Functionality for Effective Implementation
King of Prussia, PA
Aug. 19 - 21 Introduction to Molecular Biology Techniques
King of Prussia, PA
September
Sept. 9 & 10 Validation of Computer Systems
King of Prussia, PA
Sept. 9 & 10 How to Implement Risk Management Principles and Activities within a Quality Management System
King of Prussia, PA
Sept. 9 & 10 Selecting and Managing CROs
King of Prussia, PA
Sept. 11 & 12 Clinical Document Management - A Trial by Trial Approach to Compliance
King of Prussia, PA
Sept. 11 - 13 Process Validation for Medical Devices
King of Prussia, PA
Sept. 16 & 17 Successfully Handling FDA Inspections and ISO Audits for Medical Devices
King of Prussia, PA
Sept. 17 & 18 Introduction to Medical Combination Products
King of Prussia, PA
Sept. 18 – 20 ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
King of Prussia, PA
Sept. 19 & 20 Introduction to Medical Device Submissions - 510ks, PMAs, and Exemptions
King of Prussia, PA
Sep. 30 – Oct. 1 Pharmaceutical Production Batch Record Review
King of Prussia, PA