PDA 243 Current Good Manufacturing Practices CFR Parts 210 and 211

Bethesda, MD
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This comprehensive training course is designed to equip attendees with in-depth knowledge and practical skills in navigating the intricacies of Current Good Manufacturing Practice (CGMP) regulations. Through interactive sessions, case studies, and hands-on exercises, participants will gain proficiency in the following key areas:

  • Historical Overview: Participants will delve into the evolution of CGMP regulations, understanding the historical context and significant milestones shaping the current regulatory landscape.
  • Regulatory Framework: Explore the legal basis underpinning CGMP regulations, including relevant statutes, guidelines, and compliance requirements enforced by regulatory authorities.
  • Regulation Breakdown: Gain a thorough understanding of each CGMP regulation, dissecting its components, requirements, and implications for manufacturing practices.
  • Self-Assessment: Learn to critically evaluate personal work practices and organizational procedures to identify potential CGMP deficiencies and violations.
  • Application of Knowledge: Apply insights gained from CGMP regulations to propose effective changes and improvements to existing work practices and procedures, fostering a culture of compliance and continuous improvement.

By the end of this training, participants will emerge equipped with the expertise and confidence to navigate CGMP regulations adeptly, fostering a culture of compliance, quality, and excellence within their organizations.

Upon completion of this training course, the attendee will be able to:

  1. Summarize the history of the CGMP regulations
  2. Discuss the regulatory basis for the CGMP regulations
  3. Describe each of the CGMP regulations
  4. Evaluate their own work practices and procedures to identify CGMP deficiencies

For more options and/or related training courses, please visit the following page(s):

Early Registration

Register by 02 August 2024

Member Price

$2,699

GovernmentMember Only

$2,099

Health AuthorityMember Only

$2,099

AcademicMember Only

$2,099

Non-Member

$3,239

Standard Registration

Register after 02 August 2024

Member Price

$2,999

GovernmentMember Only

$2,099

Health AuthorityMember Only

$2,099

AcademicMember Only

$2,099

Non-Member

$3,599

See Qualifying Criteria for Member Types.

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 [email protected].

Featured Trainers

PLEASE 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.

Accommodations

The following hotels are located near the training course location:

Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814

Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814

Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814

How to Get Here
By Air The following airports are near the training course location: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).
By Car There is a parking garage located at the training course location. The fee is $13/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.
By Other Options Metro: Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location. Amtrak: Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.