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November 2008 November 17
“A Quality Systems Approach to Technology Transfer in the Pharmaceutical Industry”
Speaker: Frank S. Kohn, PhD Course Details>>> 2-Session Live Web Training Curriculum: November 10, November 11
“Latin America – Understanding the Structure, Regulatory Requirements and Compliance Processes for the Pharmaceutical, Biotech and Medical Device Industries”
Speaker: Robert J. Russell Course Details>>> November 4
“Quality Management Systems: Key Elements & Regulatory Expectations”
Speaker: Eugene B. Johnston, CQE / CQA
Course Details>>>
October 2008
Tuesday, October 28, 2008
"Regulatory Expectations for Biologics Facilities: an ex-FDA Inspector's Outlook"
Speaker: John R. Godshalk, Ex-FDA
Course Details>>> October 23
“Developing a Contamination Master Plan Within a GMP Manufacturing Company”
Speaker: Charles Gyecsek
Course Details>>> 3-Session Live Web Training Curriculum: October 20, October 27, November 3
“The Batch Record Review Process and Investigation of Discrepancies: Compliance, Training and Management”
Speaker: Kerry P. Potter
Course Details>>> 3-Session Live Web Training Curriculum: October 15, October 22, October 29
“Conducting Successful OOS/OOT Investigations for Analytical Testing” Speaker: Kim Huynh-Ba
Course Details>>> October 9
"How to Audit for GLP Compliance"
Speaker: Johnny Guerra, ex-FDA
Course Detail>>> October 14
“Recent Developments in the WHO/ASEAN Stability Guidance”
Speaker: Nanda Subbarao, PhD
Course Detail>>>
September 2008 September 26
"A GMP Approach to the Detection, Correction and Prevention of Human Errors"
Speaker: Johnny Guerra, ex-FDA Course Details>>> September 18
"Analytical Method Validation"
Speaker: Johnny Guerra, ex-FDA Course Details>>> September 15
“The EU Clinical Trial Directive”
Speaker: Robert J. Russell Course Details>>> 3-Session Live Web Training Curriculum: September 11 - September 18 - September 25
“Stability Data Records and Reports – A Balancing Act of Quality, Efficiency and Speed”
Speaker: Kim Huynh-Ba Course Details>>> 2-Session Live Web Training Curriculum: September 9 - September 10
“HPLC Troubleshooting”
Speaker: Laurent Saugrin Course Details>>>
August 2008 3-Session Live Web Training Curriculum: August 26 - August 27 - August 28
“Analytical Method Development and Validation”
Speaker: Hitoshi Masui, PhD Course Details>>> August 25
“Developing Stability-Indicating Methods for Pharmaceutical Products”
Speaker: Kim Huynh-Ba Course Details>>> August 21
“Immunogenicity Assays and the Current Regulatory Guidelines”
Speaker: Nanda Subbarao, PhD Course Details>>> August 18
“Auditing the QC Microbiology Laboratory for FDA Compliance”
Speaker: Frank S. Kohn, PhD Course Details>>> August 15
"A GMP Approach to the Detection, Correction and Prevention of Human Errors"
Speaker: Johnny Guerra, ex-FDA Course Details>>> August 8
"Laboratory Instrument and Equipment Qualifications"
Speaker: Johnny Guerra, ex-FDA Course Details>>>
July 2008 July 18 "Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production" Speaker: Johnny Guerra, Ex-FDA Course Details>>> 3-Session Live Web Training Curriculum: July 8 - July 9 - July 15
“A Risk-Based Approach to Inspecting Quality Systems” Speaker: Y.C. Lee, PhD. Course Details>>> 3-Session Live Web Training Curriculum: July 7 - July 14 - July 21
“Effective Standard Operating Procedures: A Complete and Successful Approach”
Speaker: Kerry P. Potter Course Details>>> 3-Session Live Web Training Curriculum: July 3 - July 17 - July 31
“A Quality Management Systems Approach to Pharmaceutical cGMP Regulations and Inspections”
Speaker: Kerry P. Potter
June 2008 June 26 "A GMP Approach to the Detection, Correction and Prevention of Human Errors" Speaker: Johnny Guerra, ex-FDA Course Details>>> June 24 "How to Audit for GLP Compliance" Speaker: Johnny Guerra, ex-FDA Course Details>>> June 17
“Validation Master Plan: Creation, Execution & Maintenance”
Speaker: Charles Gyecsek Course Details>>>
2-Session Live Web Training Curriculum: June 16 - June 23
“Analytical Method Transfer of Pharmaceutical Products” Speaker: Kim Huynh-Ba
2-Session Live Web Training Curriculum: June 12 - June 26
“Pharmaceutical Production and Process Control” Speaker: Nick Campbell Course Details>>> June 11
“Developing a Contamination Master Plan Within a GMP Manufacturing Company”
Speaker: Charles Gyecsek
June 10
"European Filings and Registrations"
Speaker: Robert J. Russell
June 5 "Change Control under the cGMP’s and fGMP’s, for the 21st Century" Speaker: Charles S. Levine Course Details>>>
May 2008 May 29
“The Best Approaches to Implement when Analyzing Environmental Microbiology Out-of-Specification (OOS) Data”
Speaker: Charles Gyecsek Course Details>>> May 27 “The EU Clinical Trial Directive” Speaker: Robert J. Russell May 27, 2008 Brochure (PDF) Course Details>>> May 21 "Strategies for Establishing an Effective Environmental Monitoring Program" Speaker: Speaker: Frank S. Kohn Course Details>>> May 15 "Laboratory Instrument and Equipment Qualifications" Speaker: Speaker: Johnny Guerra (Ex-FDA) May 15, 2008 Brochure (PDF) Course Details>>>
April 2008 April 25
“FDA Compliance for Network Infrastructure”
Speaker: Bernice Russell-Bond April 25, 2008 Brochure (PDF) April 8
"Auditing the QC Microbiology Laboratory for FDA Compliance"
Speaker: Frank S. Kohn, PhD 3-Session Web Curriculum April 2 - April 16 - April 30
“Stability Data Records and Reports – A Balancing Act of Quality, Efficiency and Speed”
Speaker: Kim Huynh-Ba 3-Session Web Curriculum April 1 - April 15 - April 29
"The Batch Record Review Process and Investigation of Discrepancies: Compliance, Training and Management"
Speaker: Kerry P. Potter
March 2008 March 25 “Good Documentation Practices Preface for the Pharmaceutical Laboratory” Speaker: Kerry P. Potter March 25, 2008 Brochure (PDF) March 20
"Analytical Method Validation"
Speaker: Johnny Guerra, ex-FDA March 13
“Developing Stability-Indicating Methods for Pharmaceutical Products”
Speaker: Kim Huynh-Ba March 13, 2008 Brochure (PDF) March 13 "Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production" Speaker: Johnny Guerra, Ex-FDA March 13, 2008 Brochure (PDF) March 11
"Change Control under the cGMP’s and fGMP’s, for the 21st Century"
Speaker: Charles S. Levine March 11, 2008 Brochure (PDF) March 4
“A Microbiological View in Obtaining Control of GMPs Within Your Manufacturing Process”
Speaker: Frank S. Kohn, PhD March 4, 2008 Brochure (PDF)
February 2008 February 28
"A GMP Approach to the Detection, Correction and Prevention of Human Errors" Speaker: Johnny Guerra, ex-FDA February 21 "Conducting Method Transfer for Pharmaceutical Products" Speaker: Kim Huynh-Ba February 21, 2008 Brochure (PDF) February 21 "Analytical Method Validation" Speaker: Johnny Guerra, ex-FDA February 20 "Pharmaceutical Water Issues - Prevent, Audit and Control" Speaker: Frank S. Kohn February 20, 2008 Brochure (PDF) February 12 “GMPs in Microbiology; the QSIT Approach” Speaker: Ziva Abraham February 7 "Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production" Speaker: Johnny Guerra, Ex-FDA February 6
“An Expert’s View of FDA Regulations, Cleaning Validation & Media Fill Standard Procedures”
Speaker: Frank S. Kohn, Ph.D February 6, 2008 Brochure (PDF)
January 2008 January 29 “Good Documentation Practices Preface for the Pharmaceutical Laboratory” Speaker: Kerry P. Potter January 24 “Current Trends of Stability Requirements for Drug Products and API” Speaker: Kim Huynh-Ba January 22, Part 1 of a 3-Part Series, "The Batch Record Review Process and Investigation of Discrepancies: Compliance, Training and Management" Speaker: Kerry P. Potter
December 2007 December 19
"Regulatory Aspects of Computer Systems Validation (CSV) and Part 11"
Speaker: Johnny Guerra December 19, 2007 Brochure (PDF) December 14
"A GMP Approach to the Detection, Correction and Prevention of Human Errors"
Speaker: Johnny Guerra December 14, 2007 Brochure (PDF) December 13
“Developing Stability-Indicating Methods for Pharmaceutical Products”
Speaker: Kim Huynh-Ba December 13, 2007 Brochure (PDF) December 11 “GMPs in Microbiology; the QSIT Approach”
Speaker: Ziva Abraham December 11, 2007 Brochure (PDF)
November 2007 November 20 "Preparing for a Successful FDA Inspection" Speaker: Kerry P. Potter November 20, 2007 Brochure (PDF) November 8 "Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production" Speaker: Johnny Guerra, Ex-FDA November 8, 2007 Brochure (PDF)
October 2007 October 30 "Change Control under the cGMP’s and fGMP’s, for the 21st Century" Speaker: Charles S. Levine October 30, 2007 Brochure (PDF) October 25 "Current Trends of Stability Requirements for Drug Products and API" Speaker: Kim Huynh-Ba October 25, 2007 Brochure (PDF)
October 23 “Defining Robust Pharmaceutical Quality Systems”; Part 1 Speaker: Calvin Koerner, Ex-FDA October 23, 2007 Brochure (PDF)
October 17
"Regulatory Aspects of Computer Systems Validation (CSV) and Part 11" Speaker: Johnny Guerra, Ex-FDA October 17, 2007 Brochure (PDF)
September 2007 September 20 "Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production" Speaker: Johnny Guerra, Ex-FDA September 20, 2007 Brochure (PDF) September 18 “FDA’s Pharmaceutical cGMPs for the 21st Century; An Inclusive Overview” Speaker: Calvin Koerner, Ex-FDA September 18, 2007 Brochure (PDF)
September 13
“Corrective Action Verifications for 483 Responses to FDA and for the Site Assessment Plan” (A continuation of Responding to 483s; Gap Analysis on a Validation Documentation System) Speaker: Kendall Young, PhD
September 11 “Responding to 483s; Gap Analysis on a Validation Documentation System” Speaker: Kendall Young, PhD
August 2007 August 30 “Auditing/Gap Analysis: QSIT Auditing for Regulatory Compliance, including Part 11, Part 211 and Part 820”
Speaker: Kendall Young, Ph.D August 21 “Generating Risk-based Computer Master Validation Plan and Supported Implementation”
Speaker: Kendall Young, PhD. August 14 “Intact Cell Mass Spectrometry for Microbe Identification and Recombinant Protein Analysis”
Speaker: Martin Winkler, Ph.D
July 2007 July 31
“An All-Encompassing Look at Laboratory Information Management Systems (LIMS)”
Speaker: Bernice Russell-Bond July 30
“A Quality System Approach to Technology Transfer in the Pharmaceutical Industry”
Speaker: Frank S. Kohn, Ph.D July 26 “An Auditor’s Guide in Preparing for FDA Audits”
Speaker: Bernice Russell-Bond July 25 “The Essentials of Essentially Managing QA/QC Departments”
Speaker: Edwin Mercado July 18 “An Expert Look at the Benefits of Quality Management Systems”
Speaker: Bernice Russell-Bond
June 2007 June 20 "Auditing for Microbiological Aspects of Pharmaceutical & Biopharmaceutical Manufacturing" Speaker: Frank S. Kohn, Ph.D June 14 "Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production"
Speaker: Johnny Guerra, Ex-FDA June 12 "The Impact of 21 CFR Part 11 on Information Systems"
Speaker: Bernice Russell-Bond
May 2007
May 29
"An Auditor’s View of FDA Requirements for QC Laboratory Compliance and A Quality System Approach to Environmental Monitoring"
Speaker: Frank S. Kohn, Ph.D May 24
“FDA Audits – How to Successfully Pass a QC Analytical Laboratory Specific Audit”
Speaker: Collin Thomas May 23 “An Inclusive Environmental Control Program for Aseptic Processing Facilities & Microbial Environmental Monitoring Program”
Speaker: Margarita Gómez, Ph.D May 3 “Best Practices in 510(k) Submissions”
Speaker: Bill McLain, RAC
March 2007
March 29
“An Expert’s Guidance for Microbial Environmental Monitoring & Environmental Control for Aseptic Processing Facilities”
Speaker: Margarita Gómez, Ph.D March 28 "A Look at Quality and Compliance"
Speaker: Frank S. Kohn, Ph.D March 27 "An Expert's View of Cleaning Validation, Media Fills Standard Procedures & Related FDA Regulations”
Speaker: Frank S. Kohn, Ph.D March 26 "A Look at Quality and Compliance" Speaker: Frank S. Kohn, Ph.D
February 2007 February 28 "A Look at Quality and Compliance”
Speaker: Frank S. Kohn, Ph.D February 14
“An Expert’s View of FDA Regulations, Cleaning Validation & Media Fill Standard Procedures”
Speaker: Frank S. Kohn, Ph.D
January 2007 January 31
"A Look at Quality and Compliance”
Speaker: Frank S. Kohn, Ph.D |
