Global Event Calendar and Registration
2013 PDA Analytical Methods Development & Validation Workshop
October 7-8, 2013 | Renaissance Baltimore Harborplace Hotel | Baltimore, Maryland
Exhibition: October 7-8
The 2013 PDA Analytical Methods Development and Validation Workshop will bring together industry professionals of all levels to network and benefit from updates on recent regulatory guidance's regarding developing and validating analytical methods. The workshop will provide participants with a comprehensive review of laboratory and documentation standards expected during the development, qualification, validation, and transfer of analytical methods. Case studies will be discussed to illustrate how analytical method lifecycle steps (development, qualification, validation, verification, comparability, transfer, post-validation maintenance, etc.) can build on each other within the biotechnology product life cycle. The workshop will also include a discussion of current recommendations for appropriate method development and validation in relation to ICH, Pharmacopoeia, PDA Technical Reports, and other relevant Regulatory Documents.
During the workshop, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends as well as networking opportunities
Learning Objectives
Attendees at this workshop will gain practical information on regulatory expectations and current industry best practices for the development and validation of analytical methods for biopharmaceutical products. Plenary sessions will address the following topics:
- Maximizing the value of all method life cycle steps
- Design strategies of development, qualification, and validation studies for various types of analytical methodologies
- Discuss the implications of Design Space during method development and validation
- Explain robustness and DOE studies during and/or after AMD studies
- Describe strategies and case studies for pre- and post-validation method transfers
- Write defendable protocols and reports using risk-based protocol acceptance criteria for validation, transfer, and comparability studies
- Utilize PDA's latest Technical Report on Analytical Method Validation for Biotechnological Products
Who Should Attend
Departments: QA/QC, CMC Project Managers and Technical Experts, CMC Regulatory Reviewers, Regulatory Affairs, Pharmaceutical, Chemical, Biotechnological and Analytical Development, Bio Pharmaceutical Development, Validation, Compliance, Engineering, Manufacturing, Research and Development, Manufacturing Outsourcing Managers, CMO Managers and Scientists
Level of Expertise: Executives, Management, Supervisors, Scientists/Technicians
Contact
Conference inquiries:
Leon D. Lewis
Director, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 149
Email: lewis@pda.org
Registration inquiries:
Patresa Day
Manager, Registration and Customer Service
Tel: +1 (301) 656-5900 ext. 115
E-mail: day@pda.org
Exhibition inquiries:
David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
Email: hall@pda.org
| Before July 26, 2013 | July 26-August 27, 2013 | After August 27, 2013 | |
| Member | $1,495 | $1,695 | $1,895 |
| Nonmember | $1,744 | $1,944 | $2,144 |
| Government/Health Authority Member | $ 700 | $ 700 | $ 700 |
| Government/Health Authority Nonmember* | $ 800 | $ 800 | $ 800 |
| Academic Member | $ 700 | $ 700 | $ 700 |
| Academic Nonmember* | $ 800 | $ 800 | $ 800 |
| Student Member | $ 280 | $ 280 | $ 280 |
| Student Nonmember* | $ 310 | $ 310 | $ 310 |
All prices in US dollars.
* For this member type, online registration is not available must be faxed in.
Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.
Please read PDA's confirmation, substitution, refund and photo release policies for this workshop and course.
Group Registration Discount
Register 4 people from the same organization as a group (at the same time) for the conference and receive the 5th registration free. Other discounts cannot be applied.
Special Dietary Requirements
Please let us know if you have any special dietary requirement we may assist you with. Please contact Patresa Day at day@pda.org for help.
Renaissance Baltimore Harborplace Hotel
202 East Pratt Street
Baltimore, Maryland 21202
Phone: + 1(410) 547-1200
Hotel Website: www.renhotels.com
Rate: Single: $179.00, plus applicable state and local taxes.
Cut Off Date: September 13th, 2013 (Rooms must be secured by this date in order to receive the PDA rate). Rates are guaranteed until the PDA block of rooms are sold out on a first come basis.
Hotel Accommodations
To make reservations at the Renaissance Baltimore Harborplace, please call the Hotel at +1 (410) 547-1200 or +1 (800) -266-9432 and reference PDA Analytical Methods Development & Validation Workshop to receive the PDA group rate. Check in time is 4:00 p.m., and check out time is 12:00 noon.
Individual Cancellation
Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 6 p.m. on the date of arrival otherwise specified on your reservation information.
Amenities
The Renaissance Baltimore Harborplace Hotel is located downtown Baltimore, near many popular inner harbor attractions, restaurants, and shopping. All 586 guest rooms and suites provide high-speed Internet, upgraded luxurious bedding, coffee makers, hair dryers, iron and an ironing board.
Travel
Area AirportsBaltimore/Washington International (BWI) is approximately 8 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Reagan Washington National (DCA) 45 miles away, and Dulles International, 60 miles away.
Ground Transportation
Taxi fares from BWI are approximately $30 one way, not including tip, and will take about 25 minutes. One way taxi fares from Dulles is approximately $185 and from DCA about $135.
Driving
Renaissance Baltimore Harborplace Hotel is located on East Pratt Street 
Train
Penn Station is approximately 1.5 miles away from the hotel.
To book your reservation call Amtrak at 1 (800) 872-7245 or visit http://www.amtrak.com/
Hotel Parking
$28/ Daily Self Parking
$40/ Daily Valet Parking
The 2013 Analytical Methods Development & Validation Workshop will bring together all levels of industry professionals to network and benefit from a program that will provide practical information on regulatory expectations and current industry best practices for the development and validation of analytical methods for biopharmaceutical products.
Find new customers, discuss ongoing projects, discover new opportunities, and reconnect with current clients by exhibiting at or sponsoring the industry’s leading conference and exhibition in this dynamic field. Extended, dedicated exhibit hours will allow ample time for information exchange with attendees and industry experts from manufacturing, quality control/assurance, CMC, regulatory affairs, development, engineering, validation, and compliance. Many high profile, cost-effective sponsorship options are available to help your company increase exposure, build awareness, and stand out from the crowd.
Become a sponsor and/or exhibit at the 2013 Analytical Methods Development & Validation Workshop and strengthen your brand image, increase your visibility, and gain access to hundreds of leaders in the industry.
For exhibition and sponsorship inquiries, please contact David Hall at +1 (240) 688-4405 or hall@pda.org.