
ComplianceOnline Virtual Seminar - Controlling Outsourcing Using Quality Principles - For Lifesciences Companies
Howard Cooper
3.2 hrs
Product Id: 701955
This course on Controlling Outsourcing Using Quality Principles will help you understand your responsibilities, while outsourcing your products, so that you avoid regulatory problems or customer alienation that can damage your product's reputation.

Dry Powder Inhalers II: Enhancing bioavailability through product design
Claudio Cerati
85 Min
Product Id: 702013
This webinar on Dry Powder Inhalers will focus on pharmaceutical active particle design, physical characteristics and its relationship with product behavior both in vitro and in vivo.

Understanding the Final Regulations under the Americans with Disabilities Amendments Act
Susan Fahey Desmond
57 Min
Product Id: 702011
This ADA Amendments webinar will help you clearly understand the EEOC's final regulations on The Americans with Disabilities Act and what it means to your company.

Adaptive Designs for Clinical Trials: How to Enhance Your Study's Chances for Success while Saving Time and Money for Your Company
Teresa Nelson,Melissa Martinson,Manya Harsch
68 Min
Product Id: 701956
This training on adaptive designs for clinical trials will help you indentify situations in which adaptive designs would be advantageous and describe the operational and administrative changes to trials under various adaptive designs.

Residual Moisture Testing - Proven Techniques
J. Jeff Schwegman
60 Min
Product Id: 701952
This training will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-dried products in vials, to foods.

Recent Major Industry CGMP Failures - Lessons Learned
John E Lincoln
105 Min
Product Id: 701897
This cGMP webinar for medical device companies will focus on recent manufacturing lapses that have resulted in major recalls, multi-million dollar fines and some criminal charges. It will analyze why they happened and show how to prevent it.

4-hr Virtual Seminar : A Comparison of ICH Q-10 Quality System and the FDA's Quality Systems Approach (QSA) to the Pharmaceutical cGMPs
Howard Cooper
3.5 hrs
Product Id: 701973
This webinar will help you understand the current quality and regulatory paradigm by comparing and analyzing ICH-Q10 Pharmaceutical Quality System and the FDA’s Quality Systems Approach (FQSA) to Pharmaceutical GMPs.

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
David Dills
64 Min
Product Id: 701826
In this medical device training on Importing and Exporting learn and understand the import and export process for unapproved and approved medical devices and the documentation process involved. Examine the import and export requirements and ensuring compliance success.

Avoiding Failure to Investigate - Observations by Conducting Effective Investigations
Felicia Ford-Rice
49 Min
Product Id: 701933
This webinar will focus on the key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid “Failure to Investigate" Observations by FDA.

Good manufacturing practices for food contact packaging producers in the US and EU
Thomas J. Dunn
57 Min
Product Id: 701959
This food safety webinar addresses components of Good Manufacturing Practices that packaging material suppliers should follow for adherence to both regulatory and voluntary standards protocols

Responsibilities of a Principal Investigator in Clinical Trials: What you Must Do to Ensure Trial Compliance
Madhavi Diwanji
60 Min
Product Id: 701868
Discussion on role and responsibilities of clinical trial investigator and the legal and regulatory requirements to follow for Good Clinical Practices (GCP)


The Pros and Cons of Alternative Working Arrangements and Regulatory Requirements in Implementing Such Programs
Susan Fahey Desmond
60 Min
Product Id: 701939
Learn the regulatory requirements and legal ramifications of alternative working arrangements - flextime programs, job sharing, telecommuting, etc.

Presenting the real GCP handbook: Build solid knowledge of GCP by learning the rules exactly as they appear in the official text
Leonidas Lambrinidis
78 Min
Product Id: 701888
Get a complete understanding of GCP through a comprehensive analysis of GCP official text - NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE, CPMP/ICH/135/95, July 2002.

Fundamentals of OSHA Injury and Illness Recordkeeping with Key Interpretations
Bill Taylor
80 Min
Product Id: 701910
This OSHA injury and illness recordkeeping webinar will explain how to determine work relatedness and determine which cases are recordable on the OSHA form 300. It will also explain key and recent OSHA recordkeeping interpretations.

PPACA - Large Employer Penalties Overview
Tony Gutierrez,Teresa C. Gutierrez
49 Min
Product Id: 701883

Full Day Virtual Webinar: Medical Device Process Validation - FDA Inspectors are Checking - Are You Prepared?
Daniel O Leary
1 Day
Product Id: 702544
Attendees will receive a detailed understanding of process validation for medical devices approach employing IQ, OQ, and PQ. You will learn the information to include in the protocols and reports, the role of Statistical Process Control (SPC), using Design of Experiments (DOE), attribute sampling plans as a verification method, and a discussion of the GHTF document on process validation.
Understanding the GHTF guidance document is particularly important, since FDA (CDRH) plans to issue it as a guidance document in FY2011.

FDA's Proposed Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List
David Dills
76 Min
Product Id: 701907
Learn about the proposed Device Establishment Registration and Listing rule and how to meet the FDA requirements and expectations.

Why You Need to Integrate Your Wellness Program with Your EHS Program
Jonathan Klane
93 Min
Product Id: 701902
Learn how to integrate wellness and occupational health and safety (OHS) , understand the list of areas to merge, where to start, what qualifications work, who to benchmark.

Alternative Food Preservation: Pasteurization
Dr. Tatiana Koutchma
60 Min
Product Id: 701886
In this Food safety training learn about Food preservation, traditional heat treatment, emerging food processing technologies, pasteurization, shelf life extension, acid and low acid foods, US FDA and USDA regulations, Health Canada, new regulatory terms and definitions, novel foods, high hydrostatic pressure, ultraviolet light, microwave heating, pulsed electric fields.