Past Seminars Images-GCPlearning.com

Applied Statistics for FDA Process Validation
By: Heath Rushing May 17th & 18th, 2018 Philadelphia, PA
Data Without Integrity Is Just Numbers: Data Integrity & Records
By: Angela Bazigos April 9th & 10th, 2018 SFO, CA
Applying ISO14971 and IEC62304 - A guide to practical Risk Management
By: Markus Weber March 27th & 28th, 2018 Zurich, Switzerland
21 CFR Part 11 compliance for software validation and SaaS/Cloud
By: David Nettleton March 14th & 15th, 2018 Zurich, Switzerland
Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result?
By: Stephanie Cooke March 1st & 2nd, 2018 Boston, MA
Validation and 21 CFR Part 11 Compliance of Computer Systems
By: Angela Bazigos March 1st & 2nd, 2018 Boston, MA
A Risk Based Approach To Data Integrity
By: Angela Bazigos February 22nd & 23rd, 2018 Los Angeles, CA
Evolution of the Quality Management System - How to go from Surviving to Thriving
By: Susanne Manz February 22nd & 23rd, 2018 Los Angeles, CA
Project Management for Non-Project Managers
By: Charles Paul February 20th & 21st, 2018 Los Angeles, CA
Tougher Import Rules for FDA Imports in 2018
By: Casper Uldriks February 15th & 16th, 2018 Dallas, TX
Risk Management in Medical Devices Industry
By: Markus Weber February 15th & 16th, 2018 Dallas, TX
The EU Clinical Trial Regulation + EU Filings & Registrations
By: Robert Russell February 14th & 15th, 2018 Zurich, Switzerland
Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)
By: David R. Dills February 7th & 8th, 2018 Zurich, Switzerland
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
By: Robert Russell February 8th & 9th, 2018 Washington, DC
Applying ISO14971 and IEC62304 - A guide to practical Risk Management
By: Markus Weber January 29th & 30th, 2018 Philadelphia, PA
Death by CAPA - Does your CAPA Program need a CAPA?
By: Susanne Manz January 29th & 30th, 2018 Philadelphia, PA
Compliance Boot Camp
By: Susanne Manz November 16th & 17th, 2017 Boston, MA
Implementing ISO 13485:2016
By: Dan O'Leary November 16th & 17th, 2017 Boston, MA
Statistics for the Non-Statistician
By: Steven Walfish November 9th & 10th, 2017 Los Angeles, CA
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
By: Dr. Ludwig Huber November 7th & 8th, 2017 Washington, DC
Project Management for Non-Project Managers
By: Charles Paul November 2nd & 3rd, 2017 Baltimore, MD
Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach
By: Dan O'Leary October 26th & 27th, 2017 San Diego, CA
Compliance Boot Camp
By: Susanne Manz October 26th & 27th, 2017 San Diego, CA
Drug dissolution testing and establishing plasma drug levels in humans
By: Dr. Saeed Qureshi October 26th & 27th, 2017 San Diego, CA
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
By: Dr. Ludwig Huber October 25th & 26th, 2017 Zurich, Switzerland
Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements
By: David R. Dills October 2nd & 3rd, 2017 UniversitatsSpital Zurich
Universities Herzzentrum Zurich
Leadership and Team Development for Managerial Success
By: Chris DeVany September 28th & 29th, 2017 Boston, MA
Data Integrity: FDA/EU Requirements and Implementation
By: Dr. Ludwig Huber September 27th & 28th, 2017 Zurich, Switzerland
Applied Statistics for FDA Process Validation
By: Richard (Rick) K. Burdick September 18th & 19th, 2017 Baltimore, MD
Supplier Management in FDA- and ISO-regulated Industry
By: Jeff Kasoff September 14th & 15th, 2017 San Diego, CA
FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use
By: Casper Uldriks September 7th & 8th, 2017 SFO, CA
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
By: Robert Russell August 17th & 18th, 2017 Chicago, IL
Implementing ISO 13485:2016
By: Dan O'Leary August 17th & 18th, 2017 Chicago, IL
21 CFR Part 11 compliance for software validation and SaaS/Cloud
By: David Nettleton August 7th & 8th, 2017 Singapore
Using Statistics to Determine Sample Size
By: Steven Walfish July 20th & 21st, 2017 Boston, MA
Documenting Software for FDA Submissions
By: Brian Shoemaker June 29th & 30th, 2017 SFO, CA
Validation and Part 11 Compliance of Computer Systems and Data
By: Dr. Ludwig Huber April 28th & 29th, 2016 Mumbai
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
By: Dr. Ludwig Huber June 7th & 8th, 2017 Zurich, Switzerland
Applied Statistics for Scientists and Engineers
By: Heath Rushing May 25th & 26th, 2017 Philadelphia, PA
Implementing ISO 13485:2016
By: Dan O'Leary April 27th & 28th, 2017 Raleigh, NC
Data Integrity Workshop: FDA Requirements and Implementation
By: Angela Bazigos May 4th & 5th, 2017 Singapore
Applied Statistics for FDA Process Validation
By: Richard (Rick) K. Burdick April 20th & 21st, 2017 San Diego, CA
HIPAA 2017
By: Brian L Tuttle April 13th & 14th, 2017 Salt Lake City, UT
Design of Experiments (DOE) for Process Development and Validation
By: Jim Wisnowski March 30th & 31st, 2017 Los Angeles, CA
Compliance Boot Camp
By: Susanne Manz March 23rd & 24th, 2017 Washington, DC
HIPAA Privacy, Security and Breach Notification Compliance: Understanding the Requirements, Preventing Incidents, Surviving Audits, and Avoiding Penalties
By: Jim Sheldon Dean March 23rd & 24th, 2017 Washington, DC
Applying ISO14971 and IEC62304 - A guide to practical Risk Management
By: Markus Weber March 9th & 10th, 2017 SFO, CA
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
By: Dr. Ludwig Huber March 8th & 9th, 2017 Zurich, Switzerland
The DHF, Technical File and Design Dossier - Similarities, Differences and The Future
By: John E Lincoln March 2nd & 3rd, 2017 Las Vegas, NV
The Complete Payroll Law
By: Miles Hutchinson February 23rd & 24th, 2017 SFO, CA
Statistics for the Non-Statistician
By: Steven Walfish February 9th & 10th, 2017 San Diego, CA
HIPAA - Understanding Compliance Program Requirements
By: Jay Hodes February 2nd & 3rd, 2017 Seattle, WA
Implementing ISO 13485:2016
By: Dan O'Leary January 26th & 27th, 2017 Phoenix, AZ
Applying ISO14971 and IEC62304 - A guide to practical Risk Management
By: Markus Weber January 19th & 20th, 2017 Boston, MA
FDA Inspection: Do's and Don'ts
By: David R Dills December 8th & 9th, 2016 Boston, MA
Master HIPAA Compliance in Six Steps
By: Paul Hales December 1st & 2nd, 2016 Baltimore, MD
New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods
By: John Ryan November 17th & 18th, 2016 Los Angeles, CA
Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices
By: Susanne Manz November 17th & 18th, 2016 Los Angeles, CA
Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC
By: John N. Zorich November 10th & 11th, 2016 Chicago, IL
Leadership and Team Development for Managerial Success
By: Chris DeVany November 10th & 11th, 2016 Chicago, IL
Supplier Management for Medical Device Manufacturers
By: Betty Lane October 24th & 25th, 2016 Zurich, Switzerland
Tougher Import Rules for FDA Imports in 2016
By: Casper Uldriks October 20th & 21st, 2016 Chicago, IL
The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems for Bio-pharma, Medical Devices and Cosmetics Industries
By: Dr. Teri C. Soli October 13th & 14th, 2016 Zurich, Switzerland
Acceptance Sampling - Methods and Applications
By: Dan O'Leary October 13th & 14th, 2016 San Francisco, CA
Verification vs. Validation - Product Process Software and QMS
By: John E Lincoln September 29th & 30th, 2016 Las Vegas, NV
Tougher Import Rules for FDA Imports in 2016
By: Casper Uldriks September 15th & 16th, 2016 Salt Lake City, UT
HIPAA for the Compliance Officer
By: Brian L Tuttle September 15th & 16th, 2016 Salt Lake City, UT
Tougher Import Rules for FDA Imports in 2016
By: Casper Uldriks August 11th & 12th, 2016 Philadelphia, PA
Statistical Process Control & Process Capability
By: Steven Wachs February 4th & 5th, 2016 Baltimore, MD
Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Coping with Rule Changes, Managing Incidents, Preparing for Audits, and Avoiding Penalties
By: Jim Sheldon Dean February 4th & 5th, 2016 Baltimore, MD
The DHF, Technical File and Design Dossier - Similarities, Differences and The Future
By: John E Lincoln January 14th & 15th, 2016 Las Vegas, NV
HIPAA Upcoming Changes
By: Brian L Tuttle January 28th & 29th, 2016 San Diego, CA
Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing
By: John N. Zorich January 21st & 22nd, 2016 Boston, MA
HIPAA Privacy Security - Time to Get Serious
By: Brian L Tuttle November 5th & 6th, 2015 Chicago, IL
Texting and E-mail with Patients: Patient Requests and Complying with HIPAA
By: Jim Sheldon Dean October 29th & 30th, 2015 SFO, CA
The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems
By: Dr. Teri C. Soli October 19th & 20th, 2015 Dhaka, Bangladesh
Verification vs. Validation - Product Process Software and QMS
By: John E Lincoln October 15th & 16th, 2015 Las Vegas, NV
Validation and Part 11 Compliance of Computer Systems and Data
By: Dr. Ludwig Huber October 6th & 7th, 2015 Zurich, Switzerland
Tougher Import Rules for FDA Imports in 2015
By: Casper Uldriks October 1st & 2nd, 2015 Washington, DC
Effective Complaint Handling, Medical Device Reporting and Recalls
Marketing Your Medical Device - From Conventional Ads to Referral Marketing and Social Media
Statistics for the Non-Statistician
Why is FDA at my Facility, and What do I do During an Inspection
Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced
The DHF, Technical File and Design Dossier - Similarities, Differences and The Future

Applied Statistics for FDA Process Validation

Data Without Integrity Is Just Numbers: Data Integrity & Records

Applying ISO14971 and IEC62304 - A guide to practical Risk Management

21 CFR Part 11 compliance for software validation and SaaS/Cloud

Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result?

Validation and 21 CFR Part 11 Compliance of Computer Systems

A Risk Based Approach To Data Integrity

Evolution of the Quality Management System - How to go from Surviving to Thriving

Project Management for Non-Project Managers

Tougher Import Rules for FDA Imports in 2018

Risk Management in Medical Devices Industry

The EU Clinical Trial Regulation + EU Filings & Registrations

Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Applying ISO14971 and IEC62304 - A guide to practical Risk Management

Death by CAPA - Does your CAPA Program need a CAPA?

Compliance Boot Camp

Implementing ISO 13485:2016

Statistics for the Non-Statistician

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

Project Management for Non-Project Managers

Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach

Compliance Boot Camp

Drug dissolution testing and establishing plasma drug levels in humans

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements

Leadership and Team Development for Managerial Success

Data Integrity: FDA/EU Requirements and Implementation

Applied Statistics for FDA Process Validation

Supplier Management in FDA- and ISO-regulated Industry

FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Implementing ISO 13485:2016

21 CFR Part 11 compliance for software validation and SaaS/Cloud

Using Statistics to Determine Sample Size

Documenting Software for FDA Submissions

Validation and Part 11 Compliance of Computer Systems and Data

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

Applied Statistics for Scientists and Engineers

Implementing ISO 13485:2016

Data Integrity Workshop: FDA Requirements and Implementation

Applied Statistics for FDA Process Validation

HIPAA 2017

Design of Experiments (DOE) for Process Development and Validation

Compliance Boot Camp

HIPAA Privacy, Security and Breach Notification Compliance: Understanding the Requirements, Preventing Incidents, Surviving Audits, and Avoiding Penalties

Applying ISO14971 and IEC62304 - A guide to practical Risk Management

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

The DHF, Technical File and Design Dossier - Similarities, Differences and The Future

The Complete Payroll Law

Statistics for the Non-Statistician

HIPAA - Understanding Compliance Program Requirements

Implementing ISO 13485:2016

Applying ISO14971 and IEC62304 - A guide to practical Risk Management

FDA Inspection: Do's and Don'ts

Master HIPAA Compliance in Six Steps

New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices

Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC

Leadership and Team Development for Managerial Success

Supplier Management for Medical Device Manufacturers

Tougher Import Rules for FDA Imports in 2016

The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems for Bio-pharma, Medical Devices and Cosmetics Industries

Acceptance Sampling - Methods and Applications

Verification vs. Validation - Product Process Software and QMS

Tougher Import Rules for FDA Imports in 2016

HIPAA for the Compliance Officer

Tougher Import Rules for FDA Imports in 2016

Statistical Process Control & Process Capability

Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Coping with Rule Changes, Managing Incidents, Preparing for Audits, and Avoiding Penalties

The DHF, Technical File and Design Dossier - Similarities, Differences and The Future

HIPAA Upcoming Changes

Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing

HIPAA Privacy Security - Time to Get Serious

Texting and E-mail with Patients: Patient Requests and Complying with HIPAA

The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

Verification vs. Validation - Product Process Software and QMS

Validation and Part 11 Compliance of Computer Systems and Data

Tougher Import Rules for FDA Imports in 2015

Effective Complaint Handling, Medical Device Reporting and Recalls