PDA Week 2024
PDA 211.3 Quality and Compliance Management for Virtual Companies
Registration Options
Individual Registration
Group Registration
Many biotech companies and some pharma companies today are small, “virtual” organizations that outsource most GxP-governed activities such as clinical trials, manufacturing, packaging, laboratory testing, and drug safety monitoring. Such companies often lack in-house knowledge of GCP, GLP and GMP requirements, or have such knowledge vested in very few people. The prospect of an FDA inspection can be a daunting one, as can ensuring that your vendors will pass FDA scrutiny.
This training course will help you understand what you need to have in place, what the high-risk areas are, and how best to manage those risks as you grow and bring activities in-house. This training course explains the GMP, GCP and GLP responsibilities of virtual companies or others who predominately outsource GxP-governed activities.
Upon completion of this training course, the attendee will be able to:
- Explain GMP and GCP requirements for virtual companies
- Decide which elements of your quality system should be managed in-house and how
For more options and/or related training courses, please visit the following page(s):
Event Location
Contact
Program Inquiries
Exhibition/Sponsorship Inquiries
Training Course Inquiries
Registration Customer Care
Standard Registration
Member Price
$1,499GovernmentMember Only
$1,049
Health AuthorityMember Only
$1,049
AcademicMember Only
$1,049
Non-Member
$1,799
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to registration@pda.org.
Featured Trainers
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David L. Chesney, MSJ
DL Chesney Consulting, LLC
Read Bio
David L. Chesney, MSJ
DL Chesney Consulting, LLC
DAVID L. CHESNEY, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He served for over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.
Mr. Chesney holds an MS in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law, a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of PDA, where he serves on the faculty of the Training and Research Institute. He is also active in the Food and Drug Law Institute and RAPS.
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Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Long Beach Convention and Entertainment Center (LBCEC)
300 E Ocean BlvdLong Beach, CA 90802, USA
Westin Long Beach
333 E Ocean Blvd, Long Beach, CA 90802
+1 (562) 436-3000
Located in the thriving downtown district, steps from the Long Beach Convention & Entertainment Center, the Westin Long Beach is designed to maximize your potential. Whether you are staying for business deals or vacation, take time to explore the area, as the Queen Mary and the Catalina Express are just moments away. Return to the hotel and maintain your health at the WestinWORKOUT® Fitness Studio or take advantage of the sunny weather with a swim in the outdoor pool. The restaurant, Navy Proof Food & Spirits, delights your palate with California Coastal cuisine and craft cocktails. Business travelers appreciate our downtown event venues, including a ballroom that seats more than 1,000 attendees. At the end of the day, settle into hotel rooms and suites featuring spacious work areas, high-speed Wi-Fi, flat-screen TVs and the Westin Heavenly® Beds. Select accommodations offer calming views of the ocean for your stay in Long Beach, CA.
Rate: $249 plus applicable taxes and fees
Reservation Link: https://book.passkey.com/e/50719719
Reservation Phone: Coming Soon!
Cut-Off: Monday,
04 March 2024
Visit Marriott Bonvoy for more details on additional reward levels and program benefits.
Renaissance Long Beach
111 E Ocean Blvd, Long Beach, CA 90802
+1 (562) 437-5900
Soak up California vibes at Renaissance Long Beach hotel – situated in the central downtown area, allowing you to immerse yourself in the neighborhood's artistic scene. From the eclectic design to our smiling team, the hotel near downtown Long Beach perfectly reflects the vibrant culture of our city. Satisfy your cravings at our on-site SIP Bar Lounge, which serves craft cocktails and California cuisine. Revel in the Pacific breezes from SIP's spacious outdoor patio or our rooftop pool with city views. At the end of the day, keep those California dreams going strong as you sink into plush bedding and surf the web with free Wi-Fi for Marriott Bonvoy members.
Rate: $269 plus applicable taxes and fees
Reservation Link: https://book.passkey.com/go/PDAMEETING2024
Reservation Phone: +1
(888) 236-2427
Cut-Off: Monday, 04 March 2024