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The PDE: A Pharmaceutical Trade Association
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Education Opportunities
The Center for Professional Innovation & Education
7 Great Valley Parkway, Suite 128
Malvern, PA
Jan. 9 – 11
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
King of Prussia, PA
Jan. 12 & 13
Pharmaceutical and Biopharmaceutical Quality Control Laboratories: A Regulatory Compliance Primer
King of Prussia, PA
Jan. 18 - 20
ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
King of Prussia, PA
Jan. 23 & 24
Best Practices for An Effective Cleaning Validation Program
King of Prussia, PA
Jan. 23 – 25
Process Validation for Medical Devices
King of Prussia, PA
Jan. 25 & 26
Process Validation for Drugs and Biologics
King of Prussia, PA
Jan. 26 & 27
How to Implement Risk Management Principles and Activities Within A Quality Management System
King of Prussia, PA
Jan. 31 & Feb.1
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
King of Prussia, PA
FEBRUARY
Feb. 1 – 3
The Drug Development Process - from Discovery to Commercialization
King of Prussia, PA
Feb. 2 & 3
Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries
King of Prussia, PA
Feb. 6 & 7
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
King of Prussia, PA
Feb. 6 – 8
Good Clinical Practices (GCPs)
King of Prussia, PA
Feb. 8 –
10 QA/QC Strategy for Biologics and Biopharmaceuticals
King of Prussia, PA
Feb. 9 & 10
Adverse Drug Events – Reporting and Regulatory Requirements
King of Prussia, PA
Feb. 14 & 15
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
King of Prussia, PA
Feb. 15 & 16
FDA Inspections -What Regulators Expect and How to Prepare
King of Prussia, PA
Feb. 27 - 29
Biostatistics for Non-Statisticians
King of Prussia, PA
Feb. 27 - 29
Lyophilization Technology - Practical Application of the Scientific Principles
King of Prussia, PA
March
Mar. 1 & 2
Introduction to Statistical Analysis of Laboratory Data
King of Prussia, PA
Mar. 5 & 6
Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, ABLAs, Post-Approval Supplements)
King of Prussia, PA
Mar. 5 & 6
Cleanroom Microbiology for the Non-Microbiologist
King of Prussia, PA
Mar. 5 – 7
Introduction to Molecular Biology Techniques - Applications in the Biotechnology and Pharmaceutical Industries
King of Prussia, PA
Mar. 7 & 8
Sterilization Procedures Technology, Equipment & Validation
King of Prussia, PA
Mar. 8 & 9
Validation of Computer Systems
King of Prussia, PA
Mar. 22 & 23
Writing Effective Standard Operating Procedures and Other Process Documents
King of Prussia, PA
Mar. 26 & 27
Writing in the Regulated Environment When English Is Your Second Language
King of Prussia, PA
Mar. 26 & 27
Project Management for Phase 1 & 2 Clinical Trials
King of Prussia, PA
Mar. 28 & 29
Project Management for Phase 3 and LCM (Life Cycle Management) of the Drug Development Process
King of Prussia, PA
Mar. 28 – 30
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
King of Prussia, PA
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