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CfPIE's Training Courses:
Website:
Pharmaceutical, Biotech and Medical Device Training from CfPIE
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Courses offered in the United States:
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February 2012
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Feb. 6 & 7
Analytical Method Validation for Biologics,
Biopharmaceuticals and Other Therapeutic Products King
of Prussia, PA
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Feb. 6 – 8
Good Clinical Practices (GCPs) King of Prussia, PA
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Feb. 6 & 7
Practical Methods for Project Management Los Angeles, CA
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Feb. 8 – 10
QA/QC Strategy for Biologics and Biopharmaceuticals King
of Prussia, PA
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Feb. 9 & 10
Adverse Drug Events – Reporting and Regulatory Requirements
King of Prussia, PA
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Feb. 9 & 10
Effective Laboratory Safety Management Los Angeles, CA
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Feb. 13 & 14
Comprehensive Overview of FDA Regulatory Compliance for
Drugs and Biotech Products King of Prussia, PA
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Feb. 14 & 15
Marketing, Advertising and Promotion of Pharmaceuticals and
Medical Devices King of Prussia, PA
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Feb. 15 & 16
FDA Inspections -What Regulators Expect and How to Prepare
King of Prussia, PA
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Feb. 27 - 29
Biostatistics for Non-Statisticians King of Prussia, PA
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Feb. 27 - 29
Lyophilization Technology - Practical Application of the
Scientific Principles King of Prussia, PA
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March 2012
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Mar. 1 & 2
Clinical Document Management - A Trial by Trial Approach to
Compliance Los Angeles, CA
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Mar. 1 & 2
Introduction to Statistical Analysis of Laboratory Data
King of Prussia, PA
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Mar. 5 & 6
Preparation of FDA Submissions and Communicating with the
FDA (INDs, NDAs, BLAs, ANDAs, ABLAs, Post-Approval
Supplements) King of Prussia, PA
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Mar. 5 & 6
Cleanroom Microbiology for the Non-Microbiologist King
of Prussia, PA
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Mar. 5 – 7
Introduction to Molecular Biology Techniques - Applications
in the Biotechnology and Pharmaceutical Industries King
of Prussia, PA
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Mar. 5 & 6
Introduction to Medical Combination Products Los
Angeles, CA
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Mar. 7 & 8
Introduction to Medical Device Submissions - 510ks, PMAs,
and Exemptions Los Angeles, CA
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Mar. 7 & 8
Sterilization Procedures Technology, Equipment & Validation
King of Prussia, PA
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Mar. 8 & 9
Validation of Computer Systems King of Prussia, PA
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Mar. 12 & 13
Design Control for Medical Device Professionals Los
Angeles, CA
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Mar. 14 & 15
Design Validation, Verification, and Risk Analysis for
Medical Device Professionals Los Angeles, CA
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Mar. 15 & 16
Preparing the CMC Section for NDAs/INDs/CTDs Los
Angeles, CA
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Mar. 19 & 20
Selecting and Managing CROs Los Angeles, CA
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Mar. 22 & 23
Writing Effective Standard Operating Procedures and Other
Process Documents King of Prussia, PA
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Mar. 26 & 27
Aseptic Processing in the Manufacture of Biotech and
Pharmaceutical Products Los Angeles, CA
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Mar. 26 & 27
Writing in the Regulated Environment When English Is Your
Second Language King of Prussia, PA
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Mar. 26 & 27
Pharmaceutical Production Batch Record Review Los
Angeles, CA
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Mar. 26 & 27
Project Management for Phase 1 & 2 Clinical Trials King
of Prussia, PA
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Mar. 28 & 29
Project Management for Phase 3 and LCM (Life Cycle
Management) of the Drug Development Process King of
Prussia, PA
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Mar. 28 – 30
Technical Writing for the Pharmaceutical, Medical Device,
and Biotech Industries King of Prussia, PA
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April 2012
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April 2 & 3
How to Monitor Pharmaceutical, Biologic and Medical Device
Clinical Trials for GCP Compliance King of Prussia, PA
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April 2 & 3
Japan - Regulatory Filing Requirements and Compliance
Processes for Life Sciences Los Angeles, CA
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April 2 & 3
Quality System Regulation for the Medical Device & Biotech
Industries King of Prussia, PA
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April 4 & 5
GCP Audits - Best Practices for Ensuring Compliance &
Detecting Fraud and Misconduct in Clinical Trials King
of Prussia, PA
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April 23 – 25
Active Pharmaceutical Ingredient (API) and Drug Product
Specifications King of Prussia, PA
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April 23 – 25
Process Validation for Medical Devices Los Angeles, CA
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April 26 & 27
How to Implement Risk Management Principles and Activities
within a Quality Management System Los Angeles, CA
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April 26 & 27
Stability Programs for Product Shelf Life - From
Development to Approval King of Prussia, PA
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May 2012
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May 1 & 2
Best Practices For An Effective Cleaning Validation
Program Los Angeles, CA
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May 2 – 4
Root Cause Analysis of Failures & Deviations - Developing
an Effective CAPA Strategy King of Prussia, PA
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May 3 & 4
Process Validation for Drugs and Biologics Los
Angeles, CA
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May 14 – 16
The Drug Development Process - From Discovery to
Commercialization Los Angeles, CA
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May 15 & 16
Effective Internal and External Quality Assurance Auditing
for FDA Regulated Industries Los Angeles, CA
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May 16 - 18
ADME, PK/TK, and Drug Metabolism in Drug Discovery and
Development Los Angeles, CA
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May 17 & 18
Auditing and Qualifying Suppliers and Vendors - An
Effective Risk Based Approach Los Angeles, CA
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May 21 & 22
The EU Clinical Trial Directive King of Prussia, PA
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May 21 & 22
Writing Effective Standard Operating Procedures and Other
Process Documents Los Angeles, CA
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May 23 & 24
Effective Document Management for the Pharmaceutical,
Biotech and Medical Device Industries Los Angeles, CA
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June 2012
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June 4 – 6
Good Clinical Practices (GCPs) Los Angeles, CA
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June 4 & 5
Practical Methods for Project Management King of
Prussia, PA
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June 7 & 8
Adverse Drug Events – Understanding and Reporting
Requirements Los Angeles, CA
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June 11 & 12
The Electronic Common Technical Document (eCTD) - Building
Comprehensive Functionality for Effective Implementation
King of Prussia, PA
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June 11 & 12
Validation of Computer Systems Los Angeles, CA
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June 11 & 12
Analytical Method Validation for Biologics,
Biopharmaceuticals and other Therapeutic Products Los
Angeles, CA
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June 12 & 13
FDA Inspections -What Regulators Expect and How to Prepare
Los Angeles, CA
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June 13 – 15
QA/QC Strategy for Biopharmaceuticals and Biologics
Los Angeles, CA
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June 18 & 19
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs,
Post-Approval Supplements) and Communicating with the FDA
Los Angeles, CA
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June 19 & 20
Comprehensive Overview of FDA Regulatory Compliance for
Medical Devices King of Prussia, PA
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June 20 – 22
CMC Regulatory Compliance for Biopharmaceuticals and
Biologics Los Angeles, CA
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June 25 - 27
Lyophilization Technology - Practical Application of the
Scientific Principles Los Angeles, CA
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June 25 & 26
Project Management for Phase 1 & 2 Clinical Trials Los
Angeles, CA
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June 25 & 26
Preparing the CMC Section for NDAs-CTDs-INDs King of
Prussia, PA
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June 27 & 28
Project Management for Phase 3 and LCM (Life Cycle
Management) of the Drug Development Process Los
Angeles, CA
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Courses offered in Europe:
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March 2012
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Mar. 14 – 16
The Drug Development Process - From Discovery to
Commercialization Berlin, Germany
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Mar. 19 – 21
Good Clinical Practices (GCPs) Berlin, Germany
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Mar. 19 – 21
cGMP Quality Principles for Pharmaceuticals,
Biopharmaceuticals, Biologics and Medical Devices
Dublin, Ireland
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Mar. 20 – 22
Lyophilization Technology - Practical Application of the
Scientific Principles Dublin, Ireland
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Mar. 26 & 27
Process Validation for Drugs and Biologics Dublin,
Ireland
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Mar. 28 & 29
Comprehensive Overview of FDA Regulatory Compliance for
Medical Devices Dublin, Ireland
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Mar. 29 & 30
EU Filing and Registration Procedures Dublin, Ireland
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April 2012
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April 12 & 13
Development and Validation of Bioanalytical Assays for
Biologics: Quantification (PK) and Immunogenicity Assays
Berlin, Germany
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April 19 & 20
Effective Document Management for the Pharmaceutical,
Biotech and Medical Device Industries Berlin,
Germany
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April 23 & 24
Analytical Method Validation for Biologics,
Biopharmaceuticals and Other Therapeutic Products
Berlin, Germany
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April 23 – 25
Technical Writing for the Pharmaceutical, Medical
Device, and Biotech Industries Berlin, Germany
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April 25 – 27
QA/QC Strategy for Biopharmaceuticals and Biologics
Berlin, Germany
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April 26 & 27
Writing Effective Standard Operating Procedures and
Other Process Documents Berlin, Germany
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May 2012
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May 7 & 8
Validation of Computer Systems Berlin, Germany
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May 14 & 15
Medical Devices – EU Directives Guidance CE Marking and ISO
Standard Certifications Dublin, Ireland
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May 16 & 17
Practical Methods for Project Management Dublin,
Ireland
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May 17 & 18
Medical Devices – Developing Effective Post Market Surveillance
and Complaint Handling Systems Dublin, Ireland
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May 21 & 22
Medical Devices – Field Actions and Their Management - Recalls,
Product Recovery, Safety Alert Dublin, Ireland
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May 21 & 22
FDA Inspections -What Regulators Expect and How to
Prepare Dublin, Ireland
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