PerkinElmer

 

 
OneSource Compliance Seminars

 

Compliance Seminar:

What the new FDA & USP updates
mean for your lab

Free seminars in your region this October ...

What attendees say ...

“The seminar was great. You’re always kind of afraid to attend a sponsored seminar like this because you’re not sure if it’s just going to be a sales pitch. The seminar was incredibly useful and very educational.”

“... This was one of the best and most informative seminars on a very relevant topic. Presentations were excellent ... Thank you."

“Thank you so much for offering a FREE seminar like this in this type of economic situation. It was informative to us.”

Find out how new FDA and USP regulatory updates affect you by attending this free one-day Compliance Seminar sponsored by PerkinElmer’s OneSource Laboratory Services.

The seminar will cover critical regulatory changes, including:

  • New FDA updates on response time for 483 warning letters and requirements for API testing by ISO 17025 accreditation laboratories
  • USP <1058> AIQ Analytical Instrument Qualification
  • Revised USP <711> Dissolution Testing, effective December 2009

Speakers include compliance experts Bob McDowall, Ph.D., author of the Questions of Quality column in LC-GC Europe, and Joe Tehrani, Ph.D., a frequent keynote speaker at compliance conferences and a specialist in writing custom qualification documentation.

Whether your laboratory is a highly regulated GxP / ISO 17025 environment or you are interested in improving internal quality processes, this seminar will teach you how to ensure compliance while reducing costs and improving lab productivity.

Seminar Locations
  • Seattle - Oct. 13
    The Westin Seattle
  • Denver - Oct. 15
    Omni Interlocken Resort
  • Chicago - Oct. 27
    Crowne Plaza Chicago O'Hare
  • Montreal, Canada - Oct. 29
    Holiday Inn Pointe-Claire
Seating is limited ... so register today
Register
 
Agenda
8.30 – 9.00 Breakfast and Registration
9.00 – 9.15 Opening Remarks
9.15 – 10.15

New FDA Regulatory Updates – 483 Response Time & API Testing by ISO 17025 Accredited Labs

Dr. Bob McDowall
Principal of McDowall Consulting

10.15 – 10.30 Break
10.30 – 11.30

USP <1058> AIQ – Harmonized Analytical Instrument Qualification

Dr. Joe Tehrani
PerkinElmer Global Qualification
and Relocation Business Leader

11.30 – 12.45 Lunch
12.45 – 1.30

Dissolution Testing: Serious Implications and Problems when Implementing Revised USP <711>

Dr. Bob McDowall
Principal of McDowall Consulting

1.30 1.45 Break
1.45 – 2.30

Cost-Effective Approach to Lab Relocation in a Compliant Environment

Ralph Dioguardi
PerkinElmer Laboratory Relocation Business Manager

2.30 – 3.00 Panel Q / A and Closing Remarks
3.00 3.30 Demo and Discussion of Metrology-Based Qualification (Optional)

 

Benefits of attending ...

  • Learn how to optimize compliance to save money and improve productivity
  • Understand and mitigate the impact of regulatory change
  • Network with a diverse audience of lab management professionals
Seating is limited ... so register today
Register

Questions? Contact Brianna Limebrook at 781-663-5798 or email Brianna.Limebrook@perkinelmer.com.

 

PerkinElmer | OneSource Laboratory Services

Keynote Speakers
Dr. Bob McDowall

As Principal of McDowall Consulting, ISO auditor and internationally recognized compliance authority, Dr. Bob McDowall has been providing compliance optimization services, with particular expertise in computerized systems validation (CSV) operating in R&D and manufacturing laboratories, for more than 15 years.

He is considered a leading compliance authority for laboratories operating in regulated environments.

He has been the author of the Questions of Quality column in LC-GC Europe since 1993 and the Focus on Quality column in Spectroscopy magazine since 2000.

Dr. Joe Tehrani

Dr. Joe Tehrani, Global Qualification and Relocation Business Leader at PerkinElmer, is a leading authority on the relocation of scientific samples and equipment, the development of compliance systems, and on the qualification and validation of laboratory instrumentation.   

He has performed hundreds of qualifications – often developing custom documentation to support specific customer requirements – and has worked with a wide array of regulated companies and organizations, ranging from pharmaceutical and biotech to consumer products and government labs, to help them ensure that their compliance programs meet internal quality, industry and government standards.

He is a frequent keynote speaker at industry events and author in trade publications such as LC/GC, American Laboratory, and Lab Manager.

Free Compliance Binder